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

NCT ID: NCT02671552

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-24
• Study Completion Date: 2014-12-04

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (contrast-enhanced ultrasound)

Patients receive perflutren protein-type A microspheres IV and then undergo contrast-enhanced ultrasound imaging the morning prior to cryosurgery and at 3-4 months post treatment during Magnetic Resonance Imaging (MRI) or computed tomography (CT) follow up.

Group Type: EXPERIMENTAL

Perflutren Protein-Type A Microspheres

Intervention Type: DRUG

Given IV

Dynamic Contrast-Enhanced Ultrasound Imaging

Intervention Type: PROCEDURE

Undergo contrast-enhanced ultrasound imaging

Interventions

Perflutren Protein-Type A Microspheres

Given IV

Intervention Type: DRUG

Dynamic Contrast-Enhanced Ultrasound Imaging

Undergo contrast-enhanced ultrasound imaging

Intervention Type: PROCEDURE

Other Intervention Names

Optison, Perflutren Protein-Type A Microspheres

Eligibility Criteria

Inclusion Criteria

• Be scheduled for a percutaneous cryoablation of a renal mass
• Be medically stable
• If a female of child-bearing potential, must have a negative pregnancy test
• Have signed informed consent to participate in the study

Exclusion Criteria

• Females who are pregnant or nursing
• Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example:

• Patients on life support or in a critical care unit
• Patients with unstable occlusive disease (eg, crescendo angina)
• Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
• Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV)
• Patients with recent cerebral hemorrhage
• Patients with known sensitivities to albumin, blood, or blood products
• Patients who have undergone surgery within 24 hours prior to the study sonographic examination
• Patients with known hypersensitivity to perflutren
• Patients who have received any contrast medium (X-ray, MRI, CT, or ultrasound [US]) in the 24 hours prior to the research US exam
• Patients with cardiac shunts
• Patients with congenital heart defects
• Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
• Patients with respiratory distress syndrome
• Patients with renal insufficiency such that they can not get intravenous contrast as part of screening or follow-up

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Flemming Forsberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://hospitals.jefferson.edu/

Thomas Jefferson University Hospital

Other Identifiers

2012-84

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2015-01470

Identifier Type: REGISTRY

Identifier Source: secondary_id

JT 3004

Identifier Type: OTHER

Identifier Source: secondary_id

12P.615

Identifier Type: -

Identifier Source: org_study_id