NCT05641935

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

Multi-Modality Detection of RCC Recurrence Post Ablation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: john eisenbrey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Renal Cell Carcinoma
• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Sulfur Hexafluoride Lipid Microspheres	Given IV
PROCEDURE	Contrast-Enhanced Ultrasound	Undergo CEUS
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Electronic Health Record Review	Review electronic medical record

Timeline

• Start date: 2022-11-03
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2022-12-08
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study