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:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT04235660
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide written informed consent and HIPAA authorization
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged ≥ 18 years at time of informed consent
* Solitary HCC (≤3 cm) diagnosed by imaging (LI-RADS 4-5) or histology
* Childs-Pugh score ≤ 7
* ECOG performance status 0-1
* Tumor location/characteristics eligible for either SBRT or Y90 therapy as deemed by local tumor board
* Adequate organ function defined as:
1. serum bilirubin \< 4.0 mg/dL ,
2. albumin \> 2 g/dL
Exclusion Criteria:
* Any prior locoregional therapy to the target tumor
* Any prior radiation therapy to the liver
* Pregnancy or lactation: Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:
i. Has undergone a hysterectomy or bilateral oophorectomy; or ii. Has been naturally amenorrheic for at least 24 consecutive months
* Known severe allergic reaction (anaphylaxis) to iodinated contrast
* Coagulopathy (platelets \< 50 K/mm3 and/or INR \> 2) not correctable by transfusion
* Macrovascular invasion or extrahepatic HCC
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04235660
Study Brief:
Protocol Section:
NCT04235660