Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast

Memorial Sloan Kettering Cancer Center42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Renal Cancer Kidney Cancer

Interventions

Ultrasound with intravenous microbubble contrast injectionDRUG

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

Sex: ALLMin age: 21 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

To determine the accuracy of contrast enhanced ultrasound of renal masses to predict benign vs. malignant histology

Time frame: conclusion of study

Secondary Outcomes

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

Data from ClinicalTrials.gov

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