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

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.

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.