Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast

Phase 1

Completed

• Conditions: Renal Cancer; Kidney Cancer
• Interventions: Drug: Ultrasound with intravenous microbubble contrast injection

• Registration Number: NCT00671411
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-05-01
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-05
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Ultrasound with intravenous microbubble contrast injection	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.

Primary Outcome Measures

Name	Time	Method
To determine the accuracy of contrast enhanced ultrasound of renal masses to predict benign vs. malignant histology	conclusion of study

Secondary Outcome Measures

Name	Time	Method
To determine if clear cell renal malignancies can be predicted, or differentiated, from other less aggressive malignant subtypes, based on analysis of the data.	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	conclusion of the study

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States