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 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT02649868
Eligibility Criteria:
* INCLUSION CRITERIA:
* Patients who are determined to be eligible for TAE by an interventional radiologist and the primary/referring team will be eligible for the study.
* Patients with pathologically proven hepatic-dominant neoplasm that might otherwise be candidates for standard clinical TAE.
* Extent of hepatic metastases is \<50% of total hepatic volume.
* At least \>=18 years of age: Because it is exceeding rare for someone under the age of 18 to develop hepatocellular carcinoma, we will exclude patients \<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
* ECOG performance status 0-2
* Six months since last treatment with Y90
* Patients must have normal or adequate organ and marrow function as defined below:
* Hematology/Absolute Neutrophil Count/ \> 1500 / mm\^3 without help of Filgrastim or other stimulating growth factors
* Hematology/Platelet Count Patient eligible if platelet count is correctable to \>=50,000/mm\^3
* Hematology/Hemoglobin Patient eligible if hemoglobin count is correctable to \>= 8.0 g/dl
* Serum Chemistry/ALT/AST \<= 5 times the upper limit of normal; except in the presence of obstructive liver metastases where ALT/AST may be up to 10 times the upper limit of normal
* Serum Chemistry/Creatinine \<1.5x institution upper limit of normal OR creatinine clearance \>= 45 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal.
* Serum Chemistry/Total Bilirubin \<=3 mg/dl
* Serum Chemistry/Prothrombin Time within 2 seconds of the upper limit of normal (INR\<=1.8)
* Ability of subject to understand and the willingness to sign a written informed consent document.
* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
EXCLUSION CRITERIA:
* No contraindications to receive iodine products.
* Main Portal Vein Occlusion or other contraindications to chemoembolization
* Patients taking immunosuppressive drugs or unable to come off of ongoing chronic anticoagulation will not be eligible.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection with systemic manifestations, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women and nursing mothers are excluded from this study because of the potential for teratogenic or abortifacient effects of required multiple imaging and associated radiation doses, anesthesia and risks during thermal ablation to the fetus. Enrolled patients 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 is participating in this study, she should inform her treating physician immediately.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT02649868
Study Brief:
Protocol Section:
NCT02649868