Contrast-Enhanced Ultrasound Imaging for Diagnosing Recurrent Renal Cell Carcinoma (RCC) Post Ablation

PRIMARY OBJECTIVE:

I. To characterize and compare the sensitivity, specificity, positive and negative predictive value, and inter-reader agreement of 2D contrast-enhanced ultrasound (CEUS) and contrast-enhanced computed tomography (CT)/magnetic resonance imaging (MRI) for detecting recurrent or residual renal cell carcinoma (RCC) following ablation, using a combination of standard of care imaging follow-up and tissue pathology as a reference standard.

SECONDARY OBJECTIVES:

I. To evaluate the potential improvement to the qualitative assessments of 2D CEUS when fused with the patient's pre-treatment cross sectional imaging.

II. To assess the potential added value of using multi-modality volumetric CEUS for detecting RCC recurrence post ablation.

III. To explore the use of quantitative imaging parameters extracted from 2D/3D CEUS datasets to determine if this improves the overall performance of CEUS.

EXPLORATORY OBJECTIVE:

I. An advanced Doppler technique designed for detection of slower flow will also be investigated as a non-contrast based approach for detecting recurrent disease.

OUTLINE:

Patients receive Lumason intravenously (IV) and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study.

Inclusion criteria

• Previously received cryotherapy or microwave therapy of RCC
• Has available contrast enhanced (CE)-MRI or CE-CT imaging prior to ablative therapy
• Have previously had or are scheduled to have a contrast-enhanced MRI/CT for the monitoring of RCC recurrence within 4 weeks of the CEUS study
• 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

• Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable
• Patients with known sensitivities to the components of Lumason