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

john eisenbrey

Status and phase: Enrolling; Phase 2

Conditions: Renal Cell Carcinoma; Recurrent Renal Cell Carcinoma

Treatments: Other: Electronic Health Record Review; Drug: Sulfur Hexafluoride Lipid Microspheres; Procedure: Computed Tomography; Procedure: Contrast-Enhanced Ultrasound; Procedure: Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05641935

JT 24546 (Other Identifier)

22F.825

R01CA269750 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

Diagnostic (CEUS with MRI/CT)

Experimental group

Description:

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

Treatment:

Procedure: Magnetic Resonance Imaging

Procedure: Contrast-Enhanced Ultrasound

Procedure: Computed Tomography

Drug: Sulfur Hexafluoride Lipid Microspheres

Other: Electronic Health Record Review