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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT02072356
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of intrahepatic malignancy including but not limited to HCC; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (AFP) and clinical findings
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
* Life expectancy \>= 3 months
* \> 4 weeks since prior radiation, surgery or chemotherapy
* Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
* Ineligible for surgical resection
Exclusion Criteria:
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times upper limit of normal (UNL)
* Serum bilirubin \> 2.0 mg/dl (unless segmental infusion is planned)
* Any contraindications to angiography and hepatic artery catheterization such as:
* History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
* Bleeding diathesis, not correctable by usual forms of therapy
* Severe peripheral vascular disease that would preclude catheterization
* Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
* Evidence of pulmonary insufficiency
* Evidence of any detectable technetium-99m macroaggregated serum albumin (Tc-99m MAA) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow
* Significant extrahepatic disease representing an imminent life-threatening outcome
* Active uncontrolled infection
* Significant underlying medical or psychiatric illness
* Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT02072356
Study Brief:
Protocol Section:
NCT02072356