Status:
COMPLETED
TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
MDS Pharma Services
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this protocol is to provide access to Therasphere treatment for patients with liver tumors.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT00683631
Start Date
January 1 2004
End Date
April 1 2021
Last Update
December 18 2023
Active Locations (1)
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1
University of Louisville Hospital / Norton Hospital
Louisville, Kentucky, United States, 40202