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Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, May 2009
First Received: May 1, 2008   Last Updated: May 18, 2009   History of Changes
Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00671411
  Purpose

The purpose of this study is to evaluate the blood flow in kidney masses by using ultrasound microbubble contrast material, and to see if results from ultrasound contrast studies can predict if a kidney mass is benign or malignant. Patterns of blood flow in the kidney mass will be examined to see if:

  1. benign kidney masses can be distinguished from kidney cancers and
  2. if slow growing, lower risk cancers have different blood flow compared to clear cell cancer which is the most common type of kidney cancer.

Condition Intervention Phase
Renal Cancer
Kidney Cancer
Procedure: Ultrasound with intravenous microbubble contrast injection
Phase II

Study Type: Interventional
Study Design: Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title: Evaluation of Renal Masses Using Ultrasound Intravenous Microbubble Contrast

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To determine the accuracy of contrast enhanced ultrasound of renal masses to predict benign vs. malignant histology [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if clear cell renal malignancies can be predicted, or differentiated, from other less aggressive malignant subtypes, based on analysis of the data. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To determine if contrast enhanced ultrasound of renal masses provides added value in predicting benign vs. malignant histology, when compared to the current routine evaluation of CT or MRI, and standard grey scale and Doppler US [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2008
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Patients entering into this protocol will also have a preoperative renal contrast enhanced US for this research study. Renal mass US contrast enhancement results will be compared with surgical pathological findings to determine if contrast enhancement patterns of the renal masses correlate with benign and malignant histopathology, and/or malignant histologic subtype.
Procedure: Ultrasound with intravenous microbubble contrast injection
Intravenous line will be inserted. After the ultrasound microbubble contrast has been suspended into solution, contrast will be injected intrav via hand bolus with a total activated suspension of 0.2 mL (30 uL octaflouropropane),followed by 10 mL saline flush, with option to rebolus 4 addit time's for tot dose of 150 uL. Post contrast cine images of renal mass will be obtained on commercially available US units primarily using low mechanical index settings & Contrast Pulsed Sequence (CPS®) technique. Images will be acquired at predetermined intervals, for up to 8 min post contrast admin. Manufacturer's guidelines incl immediate post flush image capture, as well as post admin image capture at intervals as 1 min, 2 , 4 & 8 mins. Additional, temporary higher mechanical index imaging of kidney for the purpose of "flash" bubble destruction may be optionally triggered using manufacturer's preset settings & energy w/i FDA guidelines. This will only be performed while imaging the kidney.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any adult patient who is planned or scheduled for surgical excision or biopsy of a solid or complex cystic renal mass would be eligible for the study
  • Histology of the renal mass must be unknown at the time of enrollment
  • Patients who have renal masses that are evident on conventional US imaging
  • Patients will have a correlative abdominal CT and/or MRI

Exclusion Criteria:

  • Patients with any history of cardiac shunts.
  • Patients with history of pulmonary hypertension or unstable cardiopulmonary conditions, including patients on mechanical ventilation.
  • Patients without peripheral IV access
  • Pregnant patients and children
  • Patients with any known contrast allergies, allergy to perflutren, or any components of Definity or microbubble contrast
  • Patients who have renal masses that are not evident on conventional US imaging
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671411

Contacts
Contact: Scott Gerst, MD 212-610-0706 gersts@mskcc.org
Contact: Lucy Hann, MD 212-639-2179 hannl@mskcc.org

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Scott Gerst, MD     212-610-0706     gersts@mskcc.org    
Contact: Lucy Hann, MD     212-639-2179     hannl@mskcc.org    
Principal Investigator: Scott Gerst, MD            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Scott Gerst, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Scott Gerst, MD )
Study ID Numbers: 07-165
Study First Received: May 1, 2008
Last Updated: May 18, 2009
ClinicalTrials.gov Identifier: NCT00671411     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Ultrasound

Study placed in the following topic categories:
Urinary Tract Neoplasm
Kidney Cancer
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 03, 2009