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Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast

NCT00671411 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2015-12-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Scott Gerst, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00671411 on ClinicalTrials.gov