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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02671552
• Other study ID #: 12P.615
• Secondary ID: 2012-84NCI-2015-
• Status: Withdrawn
• Phase: Early Phase 1
• First received: January 4, 2016
• Last updated: November 13, 2017
• Start date: January 24, 2013
• Est. completion date: December 4, 2014

Study information

• Verified date: November 2017
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 4, 2014
• Est. primary completion date: December 4, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• Perflutren Protein-Type A Microspheres
Given IV

Procedure:
• Dynamic Contrast-Enhanced Ultrasound Imaging
Undergo contrast-enhanced ultrasound imaging

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma	Sensitivity will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.	Up to 3-4 months after cryosurgery
Primary	Specificity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma	Specificity will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.	Up to 3-4 months after cryosurgery
Primary	Accuracy - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma	Accuracy will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.	Up to 3-4 months after cryosurgery
Primary	Positive predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma	Positive predictive value will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.	Up to 3-4 months after cryosurgery
Primary	Negative predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma	Negative predictive value will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.	Up to 3-4 months after cryosurgery
Secondary	Sensitivity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma	Inter- and intra-observer variability will be calculated.	Up to 3-4 months after cryosurgery
Secondary	Specificity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma	Inter- and intra-observer variability will be calculated.	Up to 3-4 months after cryosurgery
Secondary	Positive predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma	Inter- and intra-observer variability will be calculated.	Up to 3-4 months after cryosurgery
Secondary	Negative predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma	Inter- and intra-observer variability will be calculated.	Up to 3-4 months after cryosurgery
Secondary	Accuracy - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma	Inter- and intra-observer variability will be calculated.	Up to 3-4 months after cryosurgery

External Links

•   Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
•   Thomas Jefferson University Hospital