Clinical trial · Interventional
Treat-and-resect Study of Echo Decorrelation Imaging-controlled Radiofrequency Ablation in Liver Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of resources to execute study.
Summary
Brief summary (as posted)
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 reliable tumor treatment. The purpose of this study is to determine the ability of ultrasound echo decorrelation to successfully predict complete ablation of human hepatocellular carcinoma, concomitant diseased liver, and metastatic liver cancer and to determine the potential of echo decorrelation imaging to provide effective real-time control of radiofrequency ablation (RFA) in liver tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Tumor | Liver Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RFA controlled using echo decorrelation imaging | Procedure | — | UNRESOLVED |
| RFA controlled using standard manufacturer-specified algorithms | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- arm 1: generator-controlled RFA
- description
- In up to 6 patients (arm 1: generator-controlled RFA), RFA will be performed directly following manufacturer-specified algorithms, with recording of 3D ultrasound echo decorrelation images during ablation.
- interventionNames
- Procedure: RFA controlled using standard manufacturer-specified algorithms
- type
- EXPERIMENTAL
- label
- arm 2: imaging-controlled RFA
- description
- In up to 6 additional patients (arm 2: imaging-controlled RFA), real-time, 3D echo decorrelation imaging during ablation will provide an additional treatment end point.
- interventionNames
- Procedure: RFA controlled using echo decorrelation imaging
Primary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years. 2. 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). 3. 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. 4. Ability to understand and the willingness to sign the written research informed consent document for this study. Exclusion Criteria: 1. The tumor for which the resection is scheduled is greater than or equal to 5 cm in diameter. 2. 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. 3. 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). 4. Proceduralist assessment that research-specific radiofrequency ablation or intraoperative ultrasound imaging would cause substantial patient risk. 5. Pregnant women, prisoners, institutionalized individuals, or other individuals from vulnerable populations. 6. 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.
References
Publications (0)
Data not yet available