TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)

Study Overview
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Brief Summary
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The purpose of this protocol is to provide access to Therasphere treatment for patients with liver tumors.

Detailed Description
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Surgical resection of the affected portion of the liver offers the best chance for disease-free survival in patients with primary liver cancer (hepatocellular carcinoma (HCC)). Unfortunately, most of these patients present with disease that is not amenable to surgery (multifocal disease) or have other medical contraindications to surgery (limited hepatic reserve related to advanced cirrhosis or chronic hepatitis). Fewer than 15% of HCC patients are suitable surgical candidates. The objective of treatment with TheraSphere is to selectively administer a potentially lethal dose of radioactive material to cancerous tissue in the liver of patients with HCC. This type of regional therapy may have several advantages over systemically administered treatments and may also be of value as a 'bridging' treatment for HCC patients awaiting a donor organ for liver transplantation.

Official Title
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TheraSphere HUD For Treatment of Unresectable HCC

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Other: TheraSphere HUD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years of age, of any race or sex, who have histologic proof of primary cancer to the liver, who are able to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of greater than or equal to 2, with a life expectancy of > 3 months, non-pregnant with an acceptable contraception in premenopausal women. 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 AFP (clinical diagnosis). Participation in the TheraSphere Registry. Exclusion Criteria: Contraindications to angiography and selective visceral catheterization Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow Significant extrahepatic disease representing an imminent life-threatening outcome Severe liver dysfunction or pulmonary insufficiency Active uncontrolled infection Pregnancy Refusal to participate in the TheraSphere Registry

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TheraSphere<br>TheraSphere | Other: TheraSphere HUD<br>* TheraSphere is FDA approved under a Humanitarian Use Device. It is considered a brachytherapy device that delivers intra-arterial radiation therapy using yttrium-90 microspheres directly to liver tumors.<br>* Other names: TheraSphere HDE # 980006;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC, liver tumor, hepatocellular carcinoma, hepatoma, liver cancer