USPIO-Enhanced and Diffusion-Weighted MRI for the Detection of Pelvic Lymph Node Metastases - Full Text View

Sponsors and Collaborators:	University Hospital Inselspital, Berne Swiss National Science Foundation
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00622973

Purpose

Preoperative detection of lymph node metastases in patients with prostate or bladder cancer is crucial for selection of the appropriate treatment strategy (surgery, androgen deprivation with/or without radiation therapy or chemotherapy) and thus for patient prognosis. Until now CT or MRI have been the modalities of choice for preoperative staging procedures. However, current morphological assessment of lymph nodes based on size and shape is unable to detect smaller metastases or liable to give false positive results on lymph nodes with reactive hyperplasia. We hypothesize that USPIO-enhanced MRI combined with DW-MRI will be able to detect pelvic lymph node metastases preoperatively with high sensitivity and specificity.

Condition	Intervention	Phase
Prostate Cancer Bladder Cancer	Other: Imaging: diffusion-weighted MRI Other: Sinerem (USPIO) enhanced MRI	Phase III

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Factorial Assignment, Efficacy Study
Official Title:	Noninvasive Detection of Clinically Occult Lymph Node Metastases in Prostate and Bladder Cancer Evaluated by USPIO-Enhanced MRI and Diffusion-Weighted MRI: A Histopathological Correlation

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer Prostate Cancer Surgery

Drug Information available for: Ferumoxtran-10

U.S. FDA Resources

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:

Discrimination of N positive (N+) vs. N negative (N0) patients (prostate and bladder cancer) using diffusion-weighted imaging, USPIO enhancement and both. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Preoperative localization of all suspected positive nodes in accordance to the predefined regions on both sides and in comparison with histopathology. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology. [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	September 2007
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A Diffusion-weighted MRI	Other: Imaging: diffusion-weighted MRI Diffusion-weighted MRI of the entire pelvis to detect lymph node metastases
B Sinerem (USPIO)- enhanced MRI	Other: Sinerem (USPIO) enhanced MRI USPIO (Sinerem) will be administered intravenously immediately after the first MR examination at a dose of 2.6 mg Fe/kg body weight diluted in 100 ml of saline (optimal dose according to: (9, 10)) during a period of about 30 minutes under medical supervision. Postcontrast MR imaging will be performed 24-36 hours after contrast medium injection.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with histologically proven prostate cancer (T1-2N0M0 Gleason score 6-10) scheduled for radical prostatectomy or patients with histologically proven bladder cancer (T1-3bN0M0G3) scheduled for cystectomy
Written informed consent to participate in this trial.

Exclusion Criteria:

Patients with contraindications for MRI (e.g. pacemaker, metal implants, claustrophobia).
Patients in a critical cardiovascular state, with risk of decompensation after administration of the USPIO contrast agent.
Patients with hemochromatosis or an allergy to dextran or iron compounds.
Pregnant or breast-feeding women.
Patients who have received gadolinium complexes within 2 days or iron oxide particles within 7 days before MRI.
Patients who underwent chemotherapy or radiotherapy before surgery.
Patients whose degree of cooperation is incompatible with carrying out the study.
Patients with contraindications to Glucagon administration.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622973

Contacts

Contact: Harriet C Thoeny, MD	+41316322111 ext 6199	harriet.Thoeny@insel.ch
Contact: Frederic Birkhaeuser, MD	+41316322111 ext 8801	frederic.birkhaeuser@insel.ch

Locations

Switzerland
Inselspital	Recruiting
Bern, Switzerland, 3010
Contact: Harriet C Thoeny, MD +41316322111 ext 6199 harriet.thoeny@insel.ch
Contact: Frederic Birkhaeuser, MD +41316322111 ext 8801 frederic.birkhaeuser@insel.ch
Principal Investigator: Harriet C Thoeny, MD

Sponsors and Collaborators

University Hospital Inselspital, Berne

Swiss National Science Foundation

Investigators

Principal Investigator:

Harriet C Thoeny, MD

University Hospital Inselspital, Bern, Switzerland

More Information

Publications:

Thoeny HC, Triantafyllou M, Birkhaeuser FD, Froehlich JM, Tshering DW, Binser T, Fleischmann A, Vermathen P, Studer UE. Combined Ultrasmall Superparamagnetic Particles of Iron Oxide-Enhanced and Diffusion-Weighted Magnetic Resonance Imaging Reliably Detect Pelvic Lymph Node Metastases in Normal-Sized Nodes of Bladder and Prostate Cancer Patients. Eur Urol. 2009 Jan 7; [Epub ahead of print]

Responsible Party:	University Hospital Inselspital, Berne ( Harriet C. Thoeny, MD )
Study ID Numbers:	SNF320000-113512/1, KEK101_06, SNF320000-113512/1, SWISSMEDIC2007DR3215
Study First Received:	February 13, 2008
Last Updated:	January 19, 2009
ClinicalTrials.gov Identifier:	NCT00622973 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:

Prostate cancer
Bladder cancer
Pelvic lymph node metastases
Diffusion-weighted MRI

Sinerem (USPIO)-enhanced MRI
Imaging influence on surgery
Noninvasive detection of pelvic lymph node metastases
Influence of imaging protocol on surgical outcome

Study placed in the following topic categories:

Urinary Tract Neoplasm
Cystocele
Genital Neoplasms, Male
Prostatic Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms

Urologic Neoplasms
Genital Diseases, Male
Urologic Diseases
Neoplasm Metastasis
Bladder Neoplasm
Prostatic Neoplasms

Additional relevant MeSH terms:

Prostatic Diseases
Genital Neoplasms, Male
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Urologic Neoplasms
Genital Diseases, Male

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Urologic Diseases
Neoplasm Metastasis
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 03, 2009