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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00671411 |
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:
Condition | Intervention | Phase |
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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 |
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 |
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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.
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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.
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Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Scott Gerst, MD | 212-610-0706 | gersts@mskcc.org |
Contact: Lucy Hann, MD | 212-639-2179 | hannl@mskcc.org |
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 |
Principal Investigator: | Scott Gerst, MD | Memorial Sloan-Kettering Cancer Center |
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 |
Ultrasound |
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 |
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 |