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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT01176604
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of intrahepatic 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 alphafetoprotein (AFP) and clinical findings. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing HCC
* 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
Exclusion Criteria:
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times upper normal limit (UNL) (within 15 days of treatment demonstrating liver dysfunction)
* Serum bilirubin \> 2.0 mg/dl (unless segmental infusion is planned) (within 15 days of treatment demonstrating liver dysfunction)
* 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
* Clinical evidence of pulmonary insufficiency
* Evidence of any detectable technetium-99 macroaggregated albumin (Tc-99m MAA) flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow
* Complete occlusion of the main portal vein
* 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
* Tumor type demonstrated on imaging to be infiltrative, tumor volume \> 70% of the target liver volume, or tumor nodules too numerous to count, or tumor volume \> 50% combined with an albumin \< 3 g/dL, or complete occlusion of the main portal vein
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01176604
Study Brief:
Protocol Section:
NCT01176604