NCT02671552

Contrast-Enhanced Ultrasound in Predicting Treatment Response in Patients With Kidney Cancer Undergoing Cryosurgery

Contrast-Enhanced Ultrasound for the Evaluation of Renal Cell Carcinoma Cryoablation

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial compares the imaging results of contrast-enhanced ultrasound to contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT), the current clinical standard, in predicting treatment response in patients with kidney cancer undergoing cryosurgery (a procedure in which an extremely cold liquid or an instrument called a cryoprobe is used to freeze and destroy abnormal tissue). Using contrast-enhanced ultrasound that does not involve a dye may help patients avoid side effects from a dye that is usually used in MRI or CT and may help doctors measure blood flow and determine whether the cryosurgery procedure treated the kidney tumor.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate if contrast-enhanced ultrasound can be used to successfully evaluate the cryoablation (cryosurgery) of renal cell carcinoma. SECONDARY OBJECTIVES: I. Establish whether contrast-enhanced ultrasound provides a reliable tool for the characterization of renal masses prior to cryoablation. TERTIARY OBJECTIVES: I. Compare harmonic imaging (the current industry standard for contrast imaging) with subharmonic imaging (a novel, improved contrast imaging technique) in the two aims listed above. OUTLINE: Patients receive perflutren protein-type A microspheres intravenously (IV) and then undergo contrast-enhanced ultrasound imaging the morning prior to cryosurgery and at 3-4 months post treatment during MRI or CT follow up.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Perflutren Protein-Type A Microspheres	Given IV
PROCEDURE	Dynamic Contrast-Enhanced Ultrasound Imaging	Undergo contrast-enhanced ultrasound imaging

Timeline

• Start date: 2013-01-24
• Primary completion: 2014-12-04
• Completion: 2014-12-04
• First posted: 2016-02-02
• Last updated: 2025-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study