Status:
COMPLETED
TheraSphere & Treatment of Unresectable Primary or Unresectable Secondary Liver Cancer
Lead Sponsor:
Methodist Health System
Conditions:
Liver, Cancer of, Non-Resectable
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Protocol Synopsis Title A Humanitarian Device Exemption Use Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Neoplasia Supplier BTG International Canada Inc. Type of...
Detailed Description
Introduction TheraSphere® TheraSphere® consists of insoluble glass microspheres where Y-90 is an integral constituent of the glass. The mean sphere diameter ranges from 20 to 30 µm. Each milligram co...
Eligibility Criteria
Inclusion
- Patients over 18 years of 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 chemotherapy.
Exclusion
- Contraindications to angiography and selective visceral catheterization
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) per treatment 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 (eg, 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 pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of TheraSphere® treatment and place the patient at undue risk.
Key Trial Info
Start Date :
May 22 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2021
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT04090645
Start Date
May 22 2014
End Date
April 16 2021
Last Update
November 11 2021
Active Locations (1)
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1
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States, 75203