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

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.

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