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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT00701168
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of primary or metastatic intrahepatic carcinoma
* The cancer must be unresectable with limited established treatment options
* ECOG Performance Status Score 0-2
* Age 19 years or older
* Able to comprehend and provide written informed consent
Exclusion Criteria:
* Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
* Absolute granulocyte count ≤ 1,500/ul
* Platelet count ≤ 75,000/ul
* Serum creatinine \> 2.0 mg/dl
* Serum bilirubin ≥ 2.0 mg/dl
* Any of the following contraindications to angiography and selective visceral catheterization:
* History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
* Bleeding, diathesis, not correctable by usual forms of therapy
* Severe peripheral vascular disease that would preclude catheterization
* Substantial venous shunt away from the liver
* Evidence of potential delivery of greater than 11 mCi (20 Gy absorbed dose) of radiation to the lungs on either 1) first Therasphere® administration; or 2) cumulative delivery of radiation to the lungs over multiple treatments
* Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, application of established angiographic techniques to stop such flow
* Significant extrahepatic disease representing an imminent life- threatening situation outcome
* Severe liver dysfunction or pulmonary insufficiency
* Active uncontrolled infection
* Significant underlying medical or psychiatric illness
* Pregnant women may not participate
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT00701168
Study Brief:
Protocol Section:
NCT00701168