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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multi-Modality Detection of RCC Recurrence Post Ablation

Conditions
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Recurrent Renal Cell Carcinoma, Renal Cell Carcinoma

Intervention / Treatment
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* Drug: Sulfur Hexafluoride Lipid Microspheres
* Procedure: Contrast-Enhanced Ultrasound
* Procedure: Computed Tomography
* Procedure: Magnetic Resonance Imaging
* Other: Electronic Health Record Review


Participation Criteria
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Eligibility Criteria
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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 Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (CEUS with MRI/CT)<br>Patients receive Lumason IV and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study. | Drug: Sulfur Hexafluoride Lipid Microspheres<br>* Given IV<br>* Other names: Sulfur Hexafluoride Lipid-type A Microspheres;Procedure: Contrast-Enhanced Ultrasound<br>* Undergo CEUS<br>* Other names: CEUS;Procedure: Computed Tomography<br>* Undergo CT<br>* Other names: tomography;Procedure: Magnetic Resonance Imaging<br>* Undergo MRI<br>* Other names: nuclear magnetic resonance imaging;Other: Electronic Health Record Review<br>* Review electronic medical record<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal cell carcinoma recurrence | Baseline imaging will be reviewed and compared to the contrast enhanced imaging to diagnose recurrence. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of diagnostic imaging using 2D contrast-enhanced ultrasound (CEUS) with magnetic resonance/ computed tomography fusion | Contrast-enhanced imaging on all patients will be evaluated by radiologists at each site to determine if it increases the ability to diagnose recurrence compared to standard imaging. | Up to 2 years | 
| Measurement with multimodality 3D CEUS to improve detection of recurrence | 3D CEUS imaging will be evaluated by radiologists at each site to determine if it improved detection of recurrence. | Up to 2 years |