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

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

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT01076517
Enrollment
Unknown
Registered
2010-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

Brief summary

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

Interventions

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

Sponsors

BTG International Inc.
CollaboratorOTHER
Stanford University
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026