Status:
WITHDRAWN
Treat-and-resect Study of Echo Decorrelation Imaging-controlled Radiofrequency Ablation in Liver Tumors
Lead Sponsor:
University of Cincinnati
Conditions:
Liver Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will comprise the first pilot clinical trial of 3D, ultrasound-based thermal ablation control using echo decorrelation imaging, directly testing the capability of this approach to ensure re...
Detailed Description
To rigorously test the feasibility of 3D echo decorrelation imaging to improve the reliability of clinical thermal ablation, decorrelation-controlled ablation will be assessed in a pilot treat-and-res...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Scheduled for resection of at least one confirmed primary or metastatic liver tumor with estimated diameter \<5 cm at the University of Cincinnati Medical Center (UCMC).
- Patients may have other disease (typically cirrhosis, hepatitis B or hepatitis C) for primary liver cancer patients and extrahepatic cancer (typically colorectal) for metastatic liver cancer patients.
- Ability to understand and the willingness to sign the written research informed consent document for this study.
Exclusion
- The tumor for which the resection is scheduled is greater than or equal to 5 cm in diameter.
- The tumor for which the resection is scheduled has received: prior ablation; chemoembolization; or, other treatment which in the opinion of the PI would disqualify a patient from participation.
- Radiofrequency ablation (RFA) is contra-indicated for safety reasons in the opinion of the PI and/or clinical treatment team according to current standards of care (e.g., tumor adjacent to the heart, bowel, gall bladder, or bile ducts; impaired liver function; implanted cardiac devices).
- Proceduralist assessment that research-specific radiofrequency ablation or intraoperative ultrasound imaging would cause substantial patient risk.
- Pregnant women, prisoners, institutionalized individuals, or other individuals from vulnerable populations.
- Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI.
Key Trial Info
Start Date :
July 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05211388
Start Date
July 11 2022
End Date
January 15 2024
Last Update
August 29 2024
Active Locations (1)
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1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219