Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy

NCT ID: NCT01894607

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31

Brief Summary

The goal of this clinical research is to learn how effective an ultrasound contrast agent, called DEFINITY, is when used during ultrasound-guided surgery to remove part of one or both kidneys.

Detailed Description

DEFINITY is a contrast agent that is used to create better quality ultrasound images.

On the day before or the day of the standard of care surgery, women who are able to become pregnant must have a negative blood or urine pregnancy test. If it a blood pregnancy test is performed, a portion of blood will be used from routine blood draws that are collected as part of your standard of care surgery.

During your standard of care surgery, the radiologist will take images and videos with an ultrasound machine before you are given the contrast agent. This is done to learn if cancer has spread around the kidney.

You will then receive the DEFINITY by vein over about 1 minute. After you receive the injection of DEFINITY, the radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.

Length of Study:

Your active participation in this study will be over after you have completed the follow-up visit.

Follow-Up Phone Call:

You will have a follow-up phone call 30 days after your standard of care surgery is complete to review any side effects you may be having. This call should take about 10 minutes to complete.

This is an investigational study. DEFINITY is FDA approved and commercially available for use in contrast enhanced echocardiography. It is not FDA approved or commercially available for use in radiology.

Up to 11 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions

Kidney Cancer

Study Design

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

Study Groups

Contrast Enhanced Intraoperative Ultrasound

During standard of care surgery, radiologist will take images and videos with an ultrasound machine before patient given the contrast agent.

Patient then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.

Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having.

Group Type: EXPERIMENTAL

Contrast Enhanced Intraoperative Ultrasound

Intervention Type: PROCEDURE

During standard of care surgery, radiologist will take images and videos with an ultrasound machine before and after patient given the contrast agent.

DEFINITY

Intervention Type: DRUG

During standard of care surgery, radiologist will take images and videos with an ultrasound machine before patient given the contrast agent.

Patient then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.

Phone Call

Intervention Type: BEHAVIORAL

Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having.

Interventions

Contrast Enhanced Intraoperative Ultrasound

During standard of care surgery, radiologist will take images and videos with an ultrasound machine before and after patient given the contrast agent.

Intervention Type: PROCEDURE

DEFINITY

During standard of care surgery, radiologist will take images and videos with an ultrasound machine before patient given the contrast agent.

Patient then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.

Intervention Type: DRUG

Phone Call

Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Patients must have previous cross sectional imaging (CT or MRI) demonstrating renal mass or masses that is amenable to open partial nephrectomy.

2. Patient is scheduled for intraoperative ultrasound guided open partial nephrectomy.

3. Patient must sign informed consent, with risks and benefits of CEUS explained (see risks outlined on the following pages)

Exclusion Criteria

1. Patients with known renal mass scheduled for total or laparoscopic partial nephrectomy.

2. Patients who are hypersensitive to Definity (Perflutren Lipid Microsphere)

3. Patients with known history of right-to-left, bidirectional or transient right-to-left cardiac shunts.

4. Pediatric patients less than 18 years of age.

5. Pregnant or nursing mothers.

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

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ott Le, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

NCI-2013-02232

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012-0124

Identifier Type: -

Identifier Source: org_study_id