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

Last updated: May 1, 2025
Sponsor: john eisenbrey
Overall Status: Active - Recruiting

Phase

2

Condition

Renal Cell Carcinoma

Kidney Cancer

Carcinoma

Treatment

Sulfur Hexafluoride Lipid Microspheres

Contrast-Enhanced Ultrasound

Computed Tomography

Clinical Study ID

NCT05641935
22F.825
JT 24546
R01CA269750
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 themonitoring 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

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

Study Design

Total Participants: 210
Treatment Group(s): 5
Primary Treatment: Sulfur Hexafluoride Lipid Microspheres
Phase: 2
Study Start date:
November 03, 2022
Estimated Completion Date:
August 31, 2027

Study 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.

Connect with a study center

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

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