Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast
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|ClinicalTrials.gov Identifier: NCT00671411|
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : December 28, 2015
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:
- benign kidney masses can be distinguished from kidney cancers and
- 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 or disease||Intervention/treatment||Phase|
|Renal Cancer Kidney Cancer||Drug: Ultrasound with intravenous microbubble contrast injection||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Renal Masses Using Ultrasound Intravenous Microbubble Contrast|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
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.
Drug: 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.
- To determine the accuracy of contrast enhanced ultrasound of renal masses to predict benign vs. malignant histology [ Time Frame: conclusion of study ]
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671411
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Scott Gerst, MD||Memorial Sloan Kettering Cancer Center|