Clinical trial NCT01894607: Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy
Official title: Feasibility Study of Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Cancer
Keywords: Kidney Cancer
Renal Mass
Open partial nephrectomy
Ultrasound-guided surgery
DEFINITY
Contrast agent
Phone call
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Successful Capture of IO-CEUS Images
timeFrame: 1 day
Secondary outcomes:
measure: Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS)
timeFrame: 1 day
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ott Le, MD
role: PRINCIPAL_INVESTIGATOR
References: