Recruiting
Phase 2

Ultrasound Imaging

Sponsor:

john eisenbrey

Code:

NCT05641935

Conditions

Recurrent Renal Cell Carcinoma

Renal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sulfur Hexafluoride Lipid Microspheres

Contrast-Enhanced Ultrasound

Computed Tomography

Magnetic Resonance Imaging

Electronic Health Record Review

Study Details

Brief 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.

Conditions

Recurrent Renal Cell Carcinoma

Renal Cell Carcinoma

Study ID

NCT05641935

Start date

Nov 3, 2022

Status verified date

Feb, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

210 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (CEUS with MRI/CT)

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

Interventions

Sulfur Hexafluoride Lipid Microspheres

Given IV

Contrast-Enhanced Ultrasound

Undergo CEUS

Computed Tomography

Undergo CT

Magnetic Resonance Imaging

Undergo MRI

Electronic Health Record Review

Review electronic medical record

Primary outcome measure

  • Renal cell carcinoma recurrence [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

John Eisenbrey, PhD

215-503-5188john.eisenbrey@jefferson.edu

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

John Eisenbrey, MD

john.eisenbrey@jefferson.edu

More Information

Sponsor

john eisenbrey

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by john eisenbrey on 2026-02-17.