Contrast-Enhanced Ultrasound Imaging for Diagnosing Recurrent Renal Cell Carcinoma (RCC) Post Ablation
Multi-Modality Detection of RCC Recurrence Post Ablation
3 other identifiers
interventional
210
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2022
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 3, 2022
CompletedFirst Submitted
Initial submission to the registry
November 29, 2022
CompletedFirst Posted
Study publicly available on registry
December 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
February 17, 2026
February 1, 2026
4.8 years
November 29, 2022
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Renal cell carcinoma recurrence
Baseline imaging will be reviewed and compared to the contrast enhanced imaging to diagnose recurrence.
Up to 2 years
Secondary Outcomes (2)
Improvement of diagnostic imaging using 2D contrast-enhanced ultrasound (CEUS) with magnetic resonance/ computed tomography fusion
Up to 2 years
Measurement with multimodality 3D CEUS to improve detection of recurrence
Up to 2 years
Study Arms (1)
Diagnostic (CEUS with MRI/CT)
EXPERIMENTALPatients receive Lumason IV and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study.
Interventions
Undergo MRI
Given IV
Undergo CT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- john eisenbreylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor, Radiology
Study Record Dates
First Submitted
November 29, 2022
First Posted
December 8, 2022
Study Start
November 3, 2022
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02