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NCT05641935PHASE2Recruiting

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

john eisenbrey

Start Date

11/3/2022

Completion Date

8/31/2027

Summary

This phase II trial studies how well contrast-enhanced ultrasound (CEUS) works for diagnosing patients with renal cell cancer (RCC) that has come back (recurrent) after an ablation. Diagnostic imaging, such as CEUS, may help find and monitor long term renal cell cancer recurrence following cryo or microwave ablation.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Sulfur Hexafluoride Lipid Microspheres

PROCEDURE

Contrast-Enhanced Ultrasound

PROCEDURE

Computed Tomography

PROCEDURE

Magnetic Resonance Imaging

OTHER

Electronic Health Record Review

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Conditions

Recurrent Renal Cell CarcinomaRenal Cell Carcinoma

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States