This is the current release of the guideline.

This guideline updates a previous version: Jafri SZ, Dinan D, Francis IR, Baumgarten DA, Bluth EI, Bush WH Jr, Casalino DD, Curry NS, Israel GM, Kawashima A, Papanicolaou N, Remer EM, Sandler CM, Spring DB, Fulgham P, Expert Panel on Urologic Imaging. Pretreatment staging of invasive bladder cancer. [online publication]. Reston (VA): American College of Radiology (ACR); 2007. 8 p. [61 references]

The appropriateness criteria are reviewed biennially and updated by the panels as needed, depending on introduction of new and highly significant scientific evidence.

Invasive bladder cancer

To evaluate the appropriateness of radiologic procedures for pretreatment staging of invasive bladder cancer

Patients with invasive bladder cancer

Utility of radiologic procedures in pretreatment staging of invasive bladder cancer

Literature Search Procedure

The Medline literature search is based on keywords provided by the topic author. The two general classes of keywords are those related to the condition (e.g., ankle pain, fever) and those that describe the diagnostic or therapeutic intervention of interest (e.g., mammography, MRI).

The search terms and parameters are manipulated to produce the most relevant, current evidence to address the American College of Radiology Appropriateness Criteria (ACR AC) topic being reviewed or developed. Combining the clinical conditions and diagnostic modalities or therapeutic procedures narrows the search to be relevant to the topic. Exploding the term "diagnostic imaging" captures relevant results for diagnostic topics.

The following criteria/limits are used in the searches.

1. Articles that have abstracts available and are concerned with humans.
2. Restrict the search to the year prior to the last topic update or in some cases the author of the topic may specify which year range to use in the search. For new topics, the year range is restricted to the last 5 years unless the topic author provides other instructions.
3. May restrict the search to Adults only or Pediatrics only.
4. Articles consisting of only summaries or case reports are often excluded from final results.

The search strategy may be revised to improve the output as needed.

The total number of source documents identified as the result of the literature search is not known.

Strength of Evidence Key

Category 1 - The conclusions of the study are valid and strongly supported by study design, analysis, and results.

Category 2 - The conclusions of the study are likely valid, but study design does not permit certainty.

Category 3 - The conclusions of the study may be valid, but the evidence supporting the conclusions is inconclusive or equivocal.

Category 4 - The conclusions of the study may not be valid because the evidence may not be reliable given the study design or analysis.

The topic author drafts or revises the narrative text summarizing the evidence found in the literature. American College of Radiology (ACR) staff draft an evidence table based on the analysis of the selected literature. These tables rate the strength of the evidence for all articles included in the narrative text.

The expert panel reviews the narrative text, evidence table, and the supporting literature for each of the topic-variant combinations and assigns an appropriateness rating for each procedure listed in the table. Each individual panel member forms his/her own opinion based on his/her interpretation of the available evidence.

More information about the evidence table development process can be found in the ACR Appropriateness Criteria® Evidence Table Development document (see the "Availability of Companion Documents" field).

Modified Delphi Technique

When the data available from existing scientific studies are insufficient, the American College of Radiology Appropriateness Criteria (ACR AC) employs systematic consensus techniques to determine appropriateness. The ACR AC panels use a modified Delphi technique to determine the rating for a specific procedure. A series of surveys are conducted to elicit each individual panelist's expert opinion of the appropriateness of an imaging or therapeutic procedure for a specific clinical scenario based on the available data. ACR staff distributes surveys to the panelists along with the evidence table and narrative. Each panelist interprets the available evidence and rates each procedure. Voting surveys are completed by panelists without consulting other panelists. The ratings are integers on a scale between 1 and 9, where 1 means the panel member feels the procedure is "least appropriate" and 9 means the panel member feels the procedure is "most appropriate." Each panel member has one vote per round to assign a rating. The surveys are collected and de-identified and the results are tabulated and redistributed after each round. A maximum of three rounds are conducted. The modified Delphi technique enables each panelist to express individual interpretations of the evidence and his or her expert opinion without excessive bias from fellow panelists in a simple, standardized, and economical process.

Consensus among the panel members must be achieved to determine the final rating for each procedure. If eighty percent (80%) of the panel members agree on a single rating or one of two consecutive ratings, the final rating is determined by the rating that is closest to the median of all the ratings. Up to three voting rounds are conducted to achieve consensus.

If consensus is not reached through the modified Delphi technique, the panel is convened by conference call. The strengths and weaknesses of each imaging examination or procedure are discussed and a final rating is proposed. If the panelists on the call agree, the rating is accepted as the panel's consensus. The document is circulated to all the panelists to make the final determination. If consensus cannot be reached, "No consensus" appears in the rating column and the reasons for this decision are added to the comment sections.

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

Criteria developed by the Expert Panels are reviewed by the American College of Radiology (ACR) Committee on Appropriateness Criteria.

Note from the American College of Radiology (ACR) and the National Guideline Clearinghouse (NGC): ACR has updated its Relative Radiation Level categories and Rating Scale. The Rating Scale now includes categories (1,2,3 = Usually not appropriate; 4,5,6 = May be appropriate; 7,8,9 = Usually appropriate). See the original guideline document for details.

ACR Appropriateness Criteria®

Clinical Condition: Pretreatment Staging of Invasive Bladder Cancer

Note: Abbreviations used in the table are listed at the end of the "Major Recommendations" field.

Summary of Literature Review

The National Cancer Institute estimates that in 2009 there will be 70,980 new cases of bladder cancer and 14,300 deaths from the disease in the U.S. Bladder cancer has a high tendency toward multifocality at presentation and at recurrence after treatment. Transitional cell carcinoma of the bladder (TCCB) is the most common cell type, accounting for greater than 90% of all cases of bladder cancer. The average age of patients with TCCB in the U.S. is 65 at diagnosis. Almost 85% of patients with TCCB present with hematuria, which is either gross or microscopic and is usually painless and intermittent.

TCCB spreads by local extension through the basement membrane into the muscular layer, then to the perivesical fat. Progressive extension into the muscular layer allows vascular and lymphatic invasion and more distant spread. The most common sites of hematogenous spread are lung, bone, liver, and brain. Superficial lesions do not metastasize until they invade deeply and may remain indolent for many years. It has been estimated that 70% to 85% of TCCB is superficial at presentation, confined to the mucosa or submucosa, without muscle invasion. However, a recent population-based study from the northeastern United States reported that only 7.6% of bladder tumors identified through the New Hampshire state cancer registry were staged T2 or higher. Only invasive tumors will be considered here. The imaging workup begins after the bladder tumor has been identified or confirmed cystoscopically and has been proven by biopsy.

TCCB is staged by its extension at presentation and graded according to microscopic (pathologic) criteria of aggressiveness. The standard staging system for bladder cancer is now the Tumor, Node, Metastasis (TNM) system. The TNM system encompasses the status of the primary tumor (T), the lymph nodes (N), and any metastasis (M) (see Appendix 1 in the original guideline document).

Tumor grade relates directly to depth of invasion but inversely to curability. In a multi-institutional study from Japan, patients with pT1 (p = pathologic) or lower stage pT2, pT3, and pT4 disease without lymph node metastases had 5-year overall survival rates of 81%, 74%, 47%, and 38%, respectively. Another study of 507 patients who underwent radical cystectomy without neoadjuvant therapy had 5-year recurrence-free and overall survival rates of 73% and 62% for organ-confined, node-negative tumors and 56% and 49% for non–organ-confined, node-negative tumors. In a study of 300 cystectomy patients, there was a clear dichotomy in disease-specific survival rates between organ-confined disease (67%) and non–organ-confined disease (31%). Differentiating between microscopic (pT3a) and gross (pT3b) extravesical TCCB does not have prognostic significance for patients undergoing radical cystectomy. In such patients, recurrence-free and overall survival is significantly better in patients with lymph-node–negative disease irrespective of the extent (microscopic or gross) of extravesical involvement.

Treatment ranges from cystoscopic local excision or segmental bladder resection with pelvic lymphadenectomy for early tumors to irradiation, chemotherapy, and/or radical extirpation for deep invasion. Radical cystectomy with pelvic lymphadenectomy remains the standard treatment for muscle-invasive urothelial tumors of the bladder.

Since clinical staging by cystoscopy and bimanual examination under anesthesia is inaccurate in more than 50% of patients, imaging is vital to the proper treatment of these patients. The principal task is to identify muscle invasion, extravesical spread, and nodal metastases. Unfortunately, none of the imaging modalities can identify microscopic spread to muscle layer, perivesical fat, lymph nodes, or other organs.

Cystography, pelvic angiography, lymphangiography (LAG) with or without percutaneous fine-needle aspiration (FNA) biopsy, and radiographic whole-lung laminography are no longer routinely used in staging TCCB since the advent of cross-sectional imaging.

Intravenous Urography

Intravenous pyelography (IVU) was once the best screening examination for upper-tract disease and was the most sensitive test in detecting small urothelial lesions. With widespread use of computed tomography (CT) urography, the role of IVU in evaluating the renal collecting system and ureter is declining. Although only 60% of known bladder tumors are visualized by IVU, obstruction of a ureteral orifice at the level of the ureterovesical junction is usually due to invasive bladder tumor, if urolithiasis is excluded. Any degree of ureteric obstruction is significantly associated with both decreased overall survival rates and decreased tumor-free interval. Ureteral obstruction can also be clearly demonstrated by CT urography.

One group of investigators found synchronous TCC above the bladder in 14 of 597 (2.3%) patients with TCCB, 8 (1.3%) with ureteral TCC, and 6 (1.0%) with renal TCC. They reported a range of incidence of synchronous upper-tract lesions between 0% and 6.4% and stated that IVU "must be performed" when TCCB is first diagnosed. It is important to note that this recommendation predates the widespread availability of CT urography. Retrograde ureteropyelography is also excellent for detailed study of the urothelium, especially when IVU is contraindicated or the results are equivocal. However, recent studies have reported an incidence of upper-tract urothelium tumors of 1.1% in which IVU was able to diagnose only 66% of these cases.

Chest Radiograph and Computed Tomography of the Chest

All patients with invasive TCCB need pulmonary evaluation. The chest radiograph is an effective, inexpensive, low-morbidity screen. Patients with equivocal chest radiograph and those thought to be at high risk should have standard chest CT.

Radionuclide Bone Scan

The incidence of metastases in TCCB patients increases with tumor stage at time of diagnosis. A 4.6%positive rate was found in 458 bone scan studies. Since therapy was affected in only 0.9%, the conclusion was that scintigraphy has "no place in the routine preoperative staging of bladder carcinoma." Another study of 91 patients with precystectomy bone scan concluded that "the findings of a routine preoperative bone scan are usually unable to identify patients with bladder cancer of stage ≥T2 who will not be cured by total cystectomy." Bone scanning may be limited to patients with bone pain and/or elevated levels of serum alkaline phosphatase. Further evaluation with radiographs and/or magnetic resonance imaging (MRI) can be helpful, and, if necessary, guided needle biopsy can be definitive.

MRI of the Head

Neurologic complications directly related to TCCB are rare and usually the result of local extension rather than brain metastases. Therefore, MRI of the head is not recommended for asymptomatic patients.

Ultrasound: Transabdominal, Transrectal, and Transurethral

The distended bladder is a superb acoustic window. Size and location of the tumor affect detectability with ultrasound (US). Lesions smaller than 0.5 cm that are flat and/or near the bladder neck can be easily missed. A study of 214 bladder tumors in 85 patients showed the lowest detection rate for US for tumors located at the inferior region of the anterior wall (47%). In this same study, detection rates were significantly lower for tumors <5 mm. US is limited in visualization beyond the bladder wall and cannot reliably detect nodal enlargement. Some investigators have correlated sonographically determined contact length and height-to-length ratio with depth of tumor invasion. Color Doppler with transrectal ultrasound (TRUS) adds nothing to evaluation of stage or grade.

TRUS is excellent for evaluating prostate and seminal vesicles. Transurethral US (TUUS) is more sensitive than transabdominal US (TAUS), and TRUS and is more accurate in staging depth of wall involvement but is not widely available. TRUS provides local staging information with 62% to 100% accuracy, highest for superficial tumors. TRUS staging is unreliable for tumors ≥3 cm and tumors with calcifications, largely because of acoustic shadowing. It is poor (70%) for evaluating extravesical spread. Three-dimensional (3D) US rendering is yet another new diagnostic tool with potential to aid in discriminating superficial from muscle-invasive tumors. The use of transabdominal 3D US to detect bladder tumors was recently assessed. The combination of gray-scale US, multiplanar reconstruction, and 3D virtual US had a sensitivity of 96.4%, specificity of 88.8%, positive predictive value (PPV) of 97.6%, and negative predictive value (NPV) of 84.2% for bladder tumor detection.

Endoluminal US (ELUS), also known as intravesical US (IVUS), uses a miniature high-frequency transducer introduced by a rigid cystoscope for intravesical evaluation. ELUS is both sensitive and specific in detecting muscle invasion in bladder cancer, with rates comparable to those of TUUS, and it provides greater bladder wall detail. Limitations include difficulty in depicting the tumor base in certain locations and in depicting the depth of invasion in tumors >2 cm with broad bases.

With progression from TAUS to TRUS to TUUS and ELUS, the diagnostic accuracy of US has improved. In 214 new cases of TCCB with pathological correlation, one study reported overall accuracy of 78.6% in local staging with TAUS. They had 9.8% overstaging and 11.7% understaging. Their accuracy was 87% for stage A, 60.5% for stage B, 41.2% for stage C, and 83.3% for stage D. Another study reported an overall accuracy of 96.5% in diagnosing and staging bladder tumors with TUUS in 104 patients: 96.2% in stage Ta–T1 lesions, 100.0% in T2 lesions, 91.7% in T3 lesions, and 100.0% in T4 lesions. There was no discussion of N or M staging.

Studies have shown ELUS to be 100% sensitive, 75% specific, and 84% accurate in detecting muscle invasion in bladder cancer, with both a PPV and NPV of 100%. 3D rendering had a 66% staging accuracy for pTa tumors, 83% for pT1 tumors, and 100% for >pT1 or muscle invasive tumors.

Computed Tomography of the Pelvis and Abdomen

The primary contribution of conventional CT is distinguishing tumors that are organ confined from those with extravesical extension. It demonstrates bulky thickening of the bladder wall, perivesical extension, lymph node enlargement, and distant metastases very well. As with US, tumor location affects detection rates by CT. Identification of the primary lesion can be difficult in the areas of the anterior wall, bladder neck, and dome. CT cannot distinguish inflammatory postoperative or postradiation edema or fibrosis from tumor and cannot assess depth of invasion of the bladder wall. CT is also unable to detect microscopic or small-volume extravesical tumor extension and metastases in nonenlarged lymph nodes. The detection of peritoneal metastases from bladder cancer with CT has recently been described. In this study, CT findings of peritoneal metastases were found in eight of 105 patients and were indicative of a poor prognosis.

One group of investigators found an accuracy of 50% in CT staging of pT2 (B1) and pT3a(B2) lesions, understaging of 29.5% of cases, and overstaging of 20.5% of cases. Staging of pT3b(C) lesions was 46.2% accurate, with 53.8% understaged. Of 16 pT4 lesions, one (6.3%) was correctly diagnosed and 15 were understaged. All had infiltration into prostate or seminal vesicle.

Another study reviewed 437 cases in the literature using CT to stage TCCB. Overall accuracy ranged from 40% to 85%, with correct staging of nodes and metastases ranging from 82% to 97%. For extravesical extension, accuracy ranged from 40% to 92% with a mean of 74%. Another group found overall accuracy of 54.9%, with 39% understaging and 20.7% false negative for extravesical spread. Preoperative CT staging altered planned surgical management in only 3.7% of cases. Multi-detector row helical CT with intravenous (IV) contrast and 60-second delayed images is a highly sensitive and specific method for detecting bladder cancer and associated perivesical invasion, particularly when there is more than a 7-day time interval between intervention and CT. Its sensitivity and specificity are up to 92% and 98%, respectively, in this setting.

Various methods for bladder distention have been studied to increase the accuracy of detecting muscle invasion in bladder cancer on CT imaging. These include evaluating the bladder filled with urine, urine opacified with iodinated contrast material, and air. These methods have accuracies of approximately 84%, 89%, and 93%, respectively, with overstaging and understaging percentages comparable, ranging from 4% to 7% for overstaging and 2% to 4% for understaging.

In addition to conventional CT, helical and multidetector CT with multiplanar reformation, 3D reconstruction, and creation of images mimicking traditional cystoscopy (a technique often referred to as virtual cystoscopy or CTVC) have also been described in the literature. Using helical CT and multiplanar reformation, one group of investigators found an overall accuracy of 87.7% in CT staging of all stages of bladder cancer and, more specifically, 76.9% for Ta–T2 lesions and 94.7% for T3–T4 lesions. Pathologic lymph nodes were confirmed in six of seven cases. Multiplanar reformation was shown to be useful in evaluating the origin and extent of extravesical invasion, as well as the tumor's relationship to the ureter. A study by another group found that the sensitivity of 3D reconstruction in detecting bladder carcinomas of all stages was 76.9%. CT traditional cystography and CTVC may find use in patients unable to tolerate traditional cystoscopy, in those for whom traditional cystoscopy failed, or in those with narrow-necked bladder diverticula that may contain lesions. One group of researchers detected 96% of bladder tumors found at conventional cystoscopy with multi-detector CT (MDCT) using multiplanar reformation and CTVC, including 18 of 20 tumors ≤5 mm in size. Another group detected all but two of 14 bladder tumors in 11 patients using CTVC performed by instilling dilute contrast medium into the bladder. Both tumors missed in this study were 7 mm. CTVC provides comparable views to traditional cystoscopy but may not add additional diagnostic data in patients able to tolerate traditional cystoscopy.

Multidetector CT urography (which includes thin-section imaging of the collecting systems, ureters, and bladder during the excretory phase) provides collecting system opacification comparable to that of IVU. As upper tracts are increasingly evaluated by CT for hematuria, the addition of lower-tract evaluation adds negligible cost and avoids the discomfort that may be associated with traditional cystoscopy, thereby streamlining the evaluation of patients with hematuria. In one study, MDCT urography detected 20 urinary bladder tumors in 75 patients being evaluated for hematuria. In this study, there were two false-positive cases of bladder tumor and a false-negative case of a small (<5 mm) bladder tumor obscured by blood clot.

A 200-patient study conducted at a fast-track hematuria clinic demonstrated 93% sensitivity and 99% specificity for bladder cancer detection by CT urography, rates similar to those of traditional cystoscopy. More recently, another study found an overall sensitivity and specificity of 79% and 94%, respectively for bladder cancer detection with CT urography in a group of 779 patients. Absolute degree of contrast enhancement of tumor may correlate with histologic grade in TCCB, as demonstrated in a study of 65 patients. Although interesting, this finding may find greater application in research on tumor angiogenesis and regression post–antiangiogenesis therapy.

Magnetic Resonance Imaging

MRI is superior to CT in demonstrating the lower pelvic anatomy. There is striking inherent contrast between the bright perivesical fat and the intermediate-signal-intensity bladder wall on T1-weighted images. Multiplanar imaging and gadolinium enhancement improve visualization of tumors on T1-weighted images. Fat suppression techniques can help identify perivesical extension. Deep-muscle invasion presents as disruption of the low-signal-intensity bladder wall by tumor, which usually is of higher signal intensity on enhanced T1-weighted images. After intravenous gadolinium chelates, TCCB shows earlier and greater enhancement than normal bladder or nonmalignant tissue.

Most recently, one group of investigators demonstrated staging accuracies of 85% and 82% in differentiating superficial from muscle invasive tumors and organ-confined from non–organ-confined tumors, respectively. Additionally, the accuracy of pathologic lymph node detection was 96%. Overstaging occurred in 32% of cases. The length of time between transurethral resection and MRI did not affect staging accuracy. Another study reviewed 340 cases using MRI. The T staging of tumor was accurate in 73% to 96% of cases, and the staging of nodes and metastases was accurate in 73% to 98% of cases. The best staging results were with gadolinium-enhanced T1-weighted fast spin-echo sequences 14 seconds after injection. These authors suggest that following cystoscopic identification of tumor, MRI should be used as the initial imaging modality to stage the tumor. Another group of researchers reviewed 71 patients using gadolinium-enhanced endorectal surface coil and reported an 83% overall staging accuracy. Muscle invasion was diagnosed with 87% accuracy, 91% sensitivity, and 87% specificity. More recently, a group of researchers demonstrated that the normalized area between tumor and muscle contrast uptake curves generated with dynamic gadolinium-enhanced MRI correlates with T stage for bladder cancer. Another study found that MRI performed with ferumoxtran-10 (ultrasmall superparamagnetic iron oxide) contrast demonstrated an accuracy in pathologic lymph node detection of up to 92% and a sensitivity of up to 96%.

There has also been interest in 3D rendering techniques with magnetic resonance (MR) data sets (including multiplanar reconstructions and creation of cystoscopic-like images) as a replacement for traditional cystoscopy and to assist in staging. High diagnostic accuracy has been demonstrated, with sensitivity of 90.7% and specificity of 94.0% using combined cystoscopic-like views created from MR data sets and multiplanar reconstructions. These results are comparable to those of CT, and MR cystography is especially promising in special cases where traditional cystoscopy may be contraindicated (urethral stricture), or suboptimal (narrow-necked bladder diverticula). Similar conclusions were previously drawn by another study.

Recently, investigators have demonstrated that diffusion-weighted MRI (DWI) can differentiate between bladder carcinoma and surrounding structures and that bladder carcinoma has a lower apparent diffusion coefficient (ADC) value than surrounding, non-neoplastic structures. Further study is needed to determine if DWI can improve staging accuracy of MRI.

Computed Tomography Versus Magnetic Resonance Imaging

CT urography offers the potential for a one-stop-shop examination to assess local disease, lymph nodes, distant metastases, and the upper urinary tracts, while MRI may offer advantages over CT for local staging. Noting that MRI appears to have slightly better sensitivity and specificity than CT for local staging, one group of researchers stated that MRI and CT have similar accuracy for detecting perivesical fat invasion and that the most notable advantage of MRI is its apparent ability to differentiate between superficial and deep invasion of the bladder wall. Another group concluded that MRI is the best technique for staging invasive tumors, as it was slightly better than or equal to CT at differentiating T3a from T3b lesions and superior to CT detecting for tumors at the bladder dome or base. In deeply infiltrating tumors (stages T3b–T4b), they asserted that MRI "is generally agreed to be the most accurate staging technique," and "when MRI is available, CT is no longer needed." In a review article, it was stated that MRI is the investigation of choice for local staging and is the preferred technique in postcystectomy and radiation therapy follow-up. A more recent review contends that "MRI is superior [to CT] for evaluation of the depth of invasion in the bladder wall." These authors go on to say that "both modalities continue to have difficulties in determining whether perivesical changes are related to tumor or inflammation from the previous transurethral biopsy." Another group of researchers in a review of 143 patients prior to radiotherapy confirmed that MRI is superior to clinical staging and provided additional prognostic information.

Both CT and MRI rely on enlargement of lymph nodes as a criterion for metastasis, but they are limited in detecting metastases to normal-sized nodes. This may change as further studies corroborate the early results of using lymphotropic nanoparticle-enhanced MRI for detecting micrometastasis in nonenlarged lymph nodes. Lymph node metastasis in patients with superficial tumors (less than T3) is rare, but if deep muscle layers are involved (T2b) or if extravesical invasion is seen, the incidence of lymph node metastasis rises to 20% to 30% and 50% to 60%, respectively. If a lymph node is considered to contain metastasis, a fine-needle aspiration biopsy should be considered. Both CT and MRI are equivalent in their ability to detect nodal enlargement.

Positron Emission Tomography and Radioimmunoscintigraphy

Recently, a group of investigators reviewed the use of positron emission tomography (PET) and PET/CT for imaging of urothelial malignancies, concluding that despite advances in these techniques, larger clinical trials are needed to establish the role of these techniques for imaging urological malignancies. Conventional PET using fluorine-18-2-fluoro-2-deoxy-D-glucose (FDG) is limited for imaging bladder tumors because of its high urinary excretion, although it may have a role in detecting recurrent or metastatic disease. Preliminary results suggest that images obtained after intravenous administration of diuretic and oral hydration can improve results of FDG-PET/CT for detecting locally recurrent or residual bladder tumors. FDG-PET is 67% sensitive, 86% specific, and 80% accurate in detecting pathologic lymph nodes in patients with bladder cancer, which exceeds both CT and MRI. A study correlating FDG-PET and CT results in the same patients reported sensitivity, specificity, and accuracy of 60%, 88%, and 78%, respectively, in nodal and metastasis staging, suggesting improved distant metastatic and locoregional node staging. PET imaging with FDG may be more limited in detecting metastatic disease once a patient has received chemotherapy, with sensitivity for proven metastases of only 50% in one small series.

¹¹C-choline PET when compared with CT promises slightly increased accuracy of lymph node staging (63.0% vs. 88.9%, p<0.01) and may avoid false positive results for lymph nodes due to reactive hyperplasia when compared with CT, although further evaluation with this agent is needed to confirm these findings. A group of investigators studied ¹¹C-choline PET for preoperative staging of transitional cell carcinomas in 18 patients (17 bladder tumors), finding that uptake was present in all primary TCCs and that ¹¹C-choline PET was "highly positive for primary and metastatic bladder cancer."

The experimental modality of radioimmunoscintigraphy using anti-MUC1 mucin monoclonal antibody C595 labeled with various radiotracers has been shown to be up to 90% sensitive in detecting invasive cancer and 88% sensitive in detecting distant metastases in sites such as lymph node, bone, and lung.

Optical Coherence Tomography

Optical coherence tomography (OCT) is a new method of imaging biological tissues in vivo with exceptional spatial resolution (10–15 μm). OCT uses light generated by a superluminescent diode to image tissue in a manner analogous to B-mode US. OCT has been used to evaluate superficial bladder carcinoma with encouraging but very preliminary results. At this time, the depth and width of the scanning field are severely limited, and OCT remains experimental.

Summary

• With the increasingly widespread use of CT urography, the role of IVU is declining. CT urography not only is effective for local staging but also provides information for evaluating the upper urinary tracts, the liver, and the nodal status.
• Chest CT can be limited to those with equivocal chest radiographs.
• Radionuclide bone scan is not indicated without bone pain and/or elevated serum alkaline phosphatase levels.
• Radiographs can be limited to sites of increased uptake and/or bone pain.
• US is useful for local tumor (T) staging; TUUS and ELUS appear to be equally effective in this regard.
• Contrast-enhanced MRI is preferred over CT for local staging and is equivalent in assessing regional lymph nodes.
• CT or MRI supplemented with 3D rendering techniques may be used in specific cases such as evaluation of narrow-necked bladder diverticula, which may be poorly evaluated by traditional cystoscopy, but they are not indicated in the majority of patients.
• CT and MRI supplemented with 3D rendering techniques may also be of use in patients unable to tolerate traditional cystoscopy and may be considered to streamline evaluation of hematuria, combining staging and screening.
• MRI of the head is needed only if neurological symptoms are present.
• PET studies to date are not proven to enhance pretreatment local staging and are not indicated until further validation and studies are completed.

Anticipated Exceptions

Nephrogenic systemic fibrosis (NSF) is a disorder with a scleroderma-like presentation and a spectrum of manifestations that can range from limited clinical sequelae to fatality. It appears to be related to both underlying severe renal dysfunction and the administration of gadolinium-based contrast agents. It has occurred primarily in patients on dialysis, rarely in patients with very limited glomerular filtration rate (GFR) (i.e., <30 mL/min/1.73 m²), and almost never in other patients. There is growing literature regarding NSF. Although some controversy and lack of clarity remain, there is a consensus that it is advisable to avoid all gadolinium-based contrast agents in dialysis-dependent patients unless the possible benefits clearly outweigh the risk, and to limit the type and amount in patients with estimated GFR rates <30 mL/min/1.73 m². For more information, please see the American College of Radiology (ACR) Manual on Contrast Media (see the "Availability of Companion Documents" field).

Abbreviations

• 3D, three-dimensional
• CT, computed tomography
• FDG-PET, fluorine-18-2-fluoro-2-deoxy-D-glucose positron emission tomography
• IVU, intravenous urography
• Med, medium
• Min, minimal
• MRI, magnetic resonance imaging
• Tc, technetium
• US, ultrasound

None provided

The recommendations are based on analysis of the current literature and expert panel consensus.

Appropriate selection of radiologic imaging procedures for pretreatment staging of invasive bladder cancer

Gadolinium-based Contrast Agents

Nephrogenic systemic fibrosis (NSF) is a disorder with a scleroderma-like presentation and a spectrum of manifestations that can range from limited clinical sequelae to fatality. It appears to be related to both underlying severe renal dysfunction and the administration of gadolinium-based contrast agents. It has occurred primarily in patients on dialysis, rarely in patients with very limited glomerular filtration rate (GFR) (i.e., <30 mL/min/1.73 m²), and almost never in other patients. Although some controversy and lack of clarity remain, there is a consensus that it is advisable to avoid all gadolinium-based contrast agents in dialysis-dependent patients unless the possible benefits clearly outweigh the risk, and to limit the type and amount in patients with estimated GFR rates <30 mL/min/1.73 m². For more information, please see the American College of Radiology (ACR) Manual on Contrast Media (see the "Availability of Companion Documents" field).

Relative Radiation Level (RRL)

Potential adverse health effects associated with radiation exposure are an important factor to consider when selecting the appropriate imaging procedure. Because there is a wide range of radiation exposures associated with different diagnostic procedures, an RRL indication has been included for each imaging examination. The RRLs are based on effective dose, which is a radiation dose quantity that is used to estimate population total radiation risk associated with an imaging procedure. Additional information regarding radiation dose assessment for imaging examinations can be found in the ACR Appropriateness Criteria® Radiation Dose Assessment Introduction document (see the "Availability of Companion Documents" field).

The American College of Radiology (ACR) Committee on Appropriateness Criteria and its expert panels have developed criteria for determining appropriate imaging examinations for diagnosis and treatment of specified medical condition(s). These criteria are intended to guide radiologists, radiation oncologists, and referring physicians in making decisions regarding radiologic imaging and treatment. Generally, the complexity and severity of a patient's clinical condition should dictate the selection of appropriate imaging procedures or treatments. Only those exams generally used for evaluation of the patient's condition are ranked. Other imaging studies necessary to evaluate other co-existent diseases or other medical consequences of this condition are not considered in this document. The availability of equipment or personnel may influence the selection of appropriate imaging procedures or treatments. Imaging techniques classified as investigational by the U.S. Food and Drug Administration (FDA) have not been considered in developing these criteria; however, study of new equipment and applications should be encouraged. The ultimate decision regarding the appropriateness of any specific radiologic examination or treatment must be made by the referring physician and radiologist in light of all the circumstances presented in an individual examination.

An implementation strategy was not provided.

Not applicable: The guideline was not adapted from another source.

The American College of Radiology (ACR) provided the funding and the resources for these ACR Appropriateness Criteria®.

Committee on Appropriateness Criteria, Expert Panel on Urologic Imaging

Panel Members: John R. Leyendecker, MD (Principal Author); Isaac R. Francis, MD (Panel Chair); David D. Casalino, MD (Panel Vice-Chair); Ronald S. Arellano, MD; Deborah A. Baumgarten, MD, MPH; Nancy S. Curry, MD; Manjiri Dighe, MD; Gary M. Israel, MD; Nicholas Papanicolaou, MD; Srinivasa Prasad, MD; Parvati Ramchandani, MD; Erick M. Remer, MD; Sheila Sheth, MD; Pat Fulgham, MD

Not stated

This is the current release of the guideline.

This guideline updates a previous version: Jafri SZ, Dinan D, Francis IR, Baumgarten DA, Bluth EI, Bush WH Jr, Casalino DD, Curry NS, Israel GM, Kawashima A, Papanicolaou N, Remer EM, Sandler CM, Spring DB, Fulgham P, Expert Panel on Urologic Imaging. Pretreatment staging of invasive bladder cancer. [online publication]. Reston (VA): American College of Radiology (ACR); 2007. 8 p. [61 references]

The appropriateness criteria are reviewed biennially and updated by the panels as needed, depending on introduction of new and highly significant scientific evidence.

Electronic copies: Available in Portable Document Format (PDF) from the American College of Radiology (ACR) Web site.

Print copies: Available from the American College of Radiology, 1891 Preston White Drive, Reston, VA 20191. Telephone: (703) 648-8900.

The following are available:

• ACR Appropriateness Criteria®. Overview. Reston (VA): American College of Radiology; 2 p. Electronic copies: Available in Portable Document Format (PDF) from the American College of Radiology (ACR) Web site.
• ACR Appropriateness Criteria®. Literature search process. Reston (VA): American College of Radiology; 1 p. Electronic copies: Available in Portable Document Format (PDF) from the ACR Web site.
• ACR Appropriateness Criteria®. Evidence table development. Reston (VA): American College of Radiology; 4 p. Electronic copies: Available in Portable Document Format (PDF) from the ACR Web site.
• ACR Appropriateness Criteria®. Radiation dose assessment introduction. Reston (VA): American College of Radiology; 2 p. Electronic copies: Available in Portable Document Format (PDF) from the ACR Web site.
• ACR Appropriateness Criteria® Manual on contrast media. Reston (VA): American College of Radiology; 90 p. Electronic copies: Available in PDF from the ACR Web site.

None available

This summary was completed by ECRI on May 6, 2001. The information was verified by the guideline developer as of June 29, 2001. This summary was updated by ECRI on September 8, 2004. The updated information was verified by the guideline developer on October 8, 2004. This NGC summary was updated by ECRI on February 7, 2006. This summary was updated by ECRI Institute on May 17, 2007 following the U.S. Food and Drug Administration (FDA) advisory on Gadolinium-based contrast agents. This summary was updated by ECRI Institute on June 20, 2007 following the U.S. Food and Drug Administration (FDA) advisory on gadolinium-based contrast agents. This NGC summary was updated by ECRI Institute on December 3, 2007. This NGC summary was updated by ECRI Institute on June 17, 2010. This summary was updated by ECRI Institute on January 13, 2011 following the U.S. Food and Drug Administration (FDA) advisory on gadolinium-based contrast agents.

Instructions for downloading, use, and reproduction of the American College of Radiology (ACR) Appropriateness Criteria® may be found on the ACR Web site .