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NCT01076517 Clinical Trial

A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma

Liver Cancer Clinical Trial

Official title:
A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT01076517
Other study ID # IRB-14324 (NOT RESEARCH)
Secondary ID HEP0016
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date March 2021
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

To provide Therasphere treatment for patients diagnosed with unresectable liver cancer.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Patients of any age, of any race or sex, who have hepatocellular carcinoma of the liver, and who are able to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of </= 2, with a life expectancy of >/= 3 months, non-pregnant with an acceptable contraception in premenopausal women. Patients must be >4 weeks since prior radiation or prior surgery and at least 1 month post other chemotherapy. 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-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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Therasphere
Beta-emitting 90yttrium encapsulated in glass microspheres for intraarterial administration to the liver.

Locations
Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (2)
Lead Sponsor Collaborator
Stanford University BTG International Inc.

Country where clinical trial is conducted

United States, 

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