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

Renal Cell Carcinoma Clinical Trial

Official title:

Multi-Modality Detection of RCC Recurrence Post Ablation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05641935
• Other study ID #: 22F.825
• Secondary ID: R01CA269750
• Status: Recruiting
• Phase: Phase 2
• Start date: November 3, 2022
• Est. completion date: February 2028

Study information

• Verified date: March 2024
• Source: Thomas Jefferson University
• Contact: John Eisenbrey, PhD
• Phone: 215-503-5188
• Email: john.eisenbrey[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: February 2028
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Recurrent Renal Cell Carcinoma
• Renal Cell Carcinoma

Intervention

Drug:
• Sulfur Hexafluoride Lipid Microspheres
Given IV

Procedure:
• Contrast-Enhanced Ultrasound
Undergo CEUS
• Computed Tomography
Undergo CT
• Magnetic Resonance Imaging
Undergo MRI

Other:
• Electronic Health Record Review
Review electronic medical record

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
john eisenbrey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal cell carcinoma recurrence	Baseline imaging will be reviewed and compared to the contrast enhanced imaging to diagnose recurrence.	Up to 2 years
Secondary	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
Secondary	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