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

NCT02671552 | Withdrawn Early Phase 1 FDA Drug

• 4 other identifiers: 12P.6152012-84NCI-2015-01470JT 3004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Sensitivity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma

  Up to 3-4 months after cryosurgery

• Specificity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma

  Up to 3-4 months after cryosurgery

• Positive predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma

  Up to 3-4 months after cryosurgery

• Negative predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma

  Up to 3-4 months after cryosurgery

• Accuracy - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma

  Up to 3-4 months after cryosurgery

Study Arms (1)

Diagnostic (contrast-enhanced ultrasound)

EXPERIMENTAL

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.

Drug: Perflutren Protein-Type A Microspheres; Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging

Interventions

Perflutren Protein-Type A Microspheres DRUG

Given IV

Also known as: Optison, Perflutren Protein-Type A Microspheres

Diagnostic (contrast-enhanced ultrasound)

Dynamic Contrast-Enhanced Ultrasound Imaging PROCEDURE

Undergo contrast-enhanced ultrasound imaging

Diagnostic (contrast-enhanced ultrasound)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

FS 069

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Flemming Forsberg, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: February 2, 2016
• Study Start: January 24, 2013
• Primary Completion: December 4, 2014
• Study Completion: December 4, 2014
• Last Updated: May 2, 2025

Record last verified: 2025-05

Locations

US (1)