Two and Three Dimensional Contrast-enhanced Ultrasound for Screening of Renal Cell Carcinoma Recurrence Following Cryoablation

• Status: Completed
• Trial end date: 2018-06-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the proposed trial is to determine whether contrast-enhanced ultrasound (CEUS) can be used to assess the recurrence of renal cell carcinoma (RCC) after cryoablation compared to contrast enhanced CT or MR (the standard evaluation). This study involves the off-label use of an FDA-approved ultrasound contrast agent, Optison that flows in the vascularity. CEUS will be performed by both two and three dimensional ultrasound to examine post-cryoablation vascularity changes to screen for recurrent disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University

Criteria

Inclusion Criteria:

• Previously received cryotherapy of RCC.

• Be scheduled for contrast-enhanced MRI/CT to monitoring of RCC recurrence as part of their 8, 12, 18, 24, or 36 month CT/MRI follow up.

• Be at least 18 years of age.

• Be medically stable.

• If a female of child-bearing age, 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 (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 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.