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 @ 1:16 PM
Ignite Modification Date:
2025-12-24 @ 1:16 PM
NCT ID:
NCT05250895
Eligibility Criteria:
Inclusion Criteria:
* Age \>= 18 years
* Established HCC diagnosis, unilobar or bilobar disease
* At least 1 tumor \>= 3 cm
* Oligometastatic disease
* Barcelona Clinic Liver Cancer (BCLC) stage A, B or C
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* Life expectancy \> 12 weeks as determined by the Investigator
* The effects of Y90 Radioembolization on the developing human fetus are unknown. For this reason, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
* FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months
Exclusion Criteria:
* Patients who are definite transplant candidates
* Concurrent second malignancy outside of the liver
* Infiltrative liver tumor
* Previous liver-directed therapy to targeted tumors
* BCLC stage D
* Bilirubin \> 2 mg/dL for lobar treatment and bilirubin \> 3 mg/dL for segmental or bi-segmental Y90-SIRT
* Albumin \< 3 g/dL
* Projected lung dose of \> 30 Gy in a single session to the liver after prospective treatment planning
* Body mass index (BMI) \> 40
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05250895
Study Brief:
Protocol Section:
NCT05250895