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

Primary Purpose

Renal Cell Carcinoma

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Perflutren Protein-Type A Microspheres
Dynamic Contrast-Enhanced Ultrasound Imaging
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (contrast-enhanced ultrasound)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Sensitivity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
Inter- and intra-observer variability will be calculated.
Specificity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
Inter- and intra-observer variability will be calculated.
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.
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.
Accuracy - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
Inter- and intra-observer variability will be calculated.

Full Information

First Posted
January 4, 2016
Last Updated
November 13, 2017
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT02671552
Brief Title
Contrast-Enhanced Ultrasound in Predicting Treatment Response in Patients With Kidney Cancer Undergoing Cryosurgery
Official Title
Contrast-Enhanced Ultrasound for the Evaluation of Renal Cell Carcinoma Cryoablation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Terminated by the IRB
Study Start Date
January 24, 2013 (Actual)
Primary Completion Date
December 4, 2014 (Actual)
Study Completion Date
December 4, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (contrast-enhanced ultrasound)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Perflutren Protein-Type A Microspheres
Other Intervention Name(s)
Optison, Perflutren Protein-Type A Microspheres
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Dynamic Contrast-Enhanced Ultrasound Imaging
Intervention Description
Undergo contrast-enhanced ultrasound imaging
Primary Outcome Measure Information:
Title
Sensitivity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
Description
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.
Time Frame
Up to 3-4 months after cryosurgery
Title
Specificity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
Description
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.
Time Frame
Up to 3-4 months after cryosurgery
Title
Accuracy - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
Description
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.
Time Frame
Up to 3-4 months after cryosurgery
Title
Positive predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
Description
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.
Time Frame
Up to 3-4 months after cryosurgery
Title
Negative predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
Description
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.
Time Frame
Up to 3-4 months after cryosurgery
Secondary Outcome Measure Information:
Title
Sensitivity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
Description
Inter- and intra-observer variability will be calculated.
Time Frame
Up to 3-4 months after cryosurgery
Title
Specificity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
Description
Inter- and intra-observer variability will be calculated.
Time Frame
Up to 3-4 months after cryosurgery
Title
Positive predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
Description
Inter- and intra-observer variability will be calculated.
Time Frame
Up to 3-4 months after cryosurgery
Title
Negative predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
Description
Inter- and intra-observer variability will be calculated.
Time Frame
Up to 3-4 months after cryosurgery
Title
Accuracy - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
Description
Inter- and intra-observer variability will be calculated.
Time Frame
Up to 3-4 months after cryosurgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flemming Forsberg, PhD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

Learn more about this trial

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

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