A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma
NCT ID: NCT01076517
Last Updated: 2021-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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APPROVED_FOR_MARKETING
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Therasphere
Beta-emitting 90yttrium encapsulated in glass microspheres for intraarterial administration to the liver.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs
* Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (ex. placing catheter distal to gastric vessels)
* Significant extrahepatic disease representing an imminent life-threatening outcome
* Severe liver dysfunction or pulmonary insufficiency
* Active uncontrolled infection
* Significant underlying medical or psychiatric illness
* Pregnancy
Patients will be excluded: if they have a co-morbid disease or an acute or chronic condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.
ALL
No
Sponsors
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BTG International Inc.
OTHER
Stanford University
OTHER
Responsible Party
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Daniel Yung-Ho Sze
Professor of Radiology
Principal Investigators
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Daniel Yung-Ho Sze
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Stanford, California, United States
Countries
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Other Identifiers
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HEP0016
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-14324 (NOT RESEARCH)
Identifier Type: -
Identifier Source: org_study_id
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