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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT04933435
Eligibility Criteria:
Inclusion Criteria:
* HCC diagnosed either by histology/pathology or Liver Imaging Reporting and Data System (LIRADs 5 per the ACR's LIRADs criteria 10) by CT or MRI
* Patient is 18 years or older
* ECOG Performance status of 0-2
* Child Pugh score A5, A6, B7 or B8 (see Appendix)
* Lesion ≤ 5cm in size
* ≤ 3 lesions in the liver to be treated on protocol
* Lesion amenable to treatment with both Interventional Radiology Liver Directed Therapies and HIGRT.
Exclusion Criteria:
* Child Pugh score B9 or Class C
* Fluctuating ascites
* Inability to complete baseline Quality of Life survey forms
* Concurrent administration of systemic therapy for hepatocellular carcinoma
* Prior liver radiation therapy is an exclusion unless subject participation is approved by the PI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04933435
Study Brief:
Protocol Section:
NCT04933435