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Trial Title:
A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma
NCT ID:
NCT01076517
Condition:
Liver Cancer
Conditions: Official terms:
Carcinoma, Hepatocellular
Study type:
Expanded Access
Overall status:
Approved for marketing
Intervention:
Intervention type:
Device
Intervention name:
Therasphere
Description:
Beta-emitting 90yttrium encapsulated in glass microspheres for intraarterial
administration to the liver.
Other name:
HCC
Other name:
hepatocellular carcinoma treatment
Summary:
To provide Therasphere treatment for patients diagnosed with unresectable liver cancer.
Criteria for eligibility:
Criteria:
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 /= 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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford University School of Medicine
Address:
City:
Stanford
Zip:
94305
Country:
United States
Lead sponsor:
Agency:
Stanford University
Agency class:
Other
Collaborator:
Agency:
BTG International Inc.
Agency class:
Other
Source:
Stanford University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01076517
