NCT01894607

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
DRUG	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.
BEHAVIORAL	Phone Call	Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-12-01
• First posted: 2013-07-10
• Last updated: 2016-04-14
• Results posted: 2016-03-15

Locations

1 site across 1 country: United States