NCT00671411

Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast

Evaluation of Renal Masses Using Ultrasound Intravenous Microbubble Contrast

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Renal Cancer
• Kidney Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2008-05-05
• Last updated: 2015-12-28

Locations

1 site across 1 country: United States