Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT07226869
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years, with life expectancy of at least 1 year
2. Diagnosis of hepatocellular carcinoma (HCC) confirmed by:
* LI-RADS 5 imaging features or
* Histopathology
* Cirrhosis with AFP \> 400
3. Localized disease without macrovascular invasion or extrahepatic metastasis, eligible for curative-intent percutaneous thermal ablation, defined as:
o Up to 5 lesions with at least one lesion, 2 -5 cm, and no lesion \>5 cm diameter
4. Tumor location deemed technically feasible for percutaneous ablation by the treating interventional radiologist
5. ECOG Performance Status 0-2
6. Adequate coagulation status, defined as:
* Platelets ≥ 50,000/μL
* INR ≤ 1.8 (or correctable)
7. Ability to undergo contrast-enhanced CT or MRI
8. Willingness and ability to provide informed consent
Exclusion Criteria:
1. Prior local therapy to the target lesion (ablation, TACE, SBRT, or resection) or to a lesion within 1 cm of the target lesion
2. More than 5 hepatic lesions, or any lesion ineligible for technically complete ablation
3. uncontrolled hepatic decompensation, including:
o Persistent encephalopathy
4. Uncorrectable coagulopathy or contraindication to percutaneous liver intervention
5. Contraindication to contrast-enhanced imaging (e.g., severe CKD without dialysis, contrast allergy not correctable with premedication)
6. Active systemic infection
7. Pregnancy
8. Inability to comply with follow-up imaging schedule
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT07226869
Study Brief:
Protocol Section:
NCT07226869