A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma
Trial ID or NCT#
NCT01076517
Status
NOT RECRUITING
Purpose
To provide Therasphere treatment for patients diagnosed with unresectable liver cancer.
Official Title
A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma
Eligibility Criteria
Sexes Eligible for Study: ALL
Accepts 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 \/= 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.
Investigator(s)
David S. Wang, MD
Interventional radiologist,
Radiologist,
Minimally invasive surgeon,
Diagnostic radiologist
Clinical Associate Professor, Radiology
Contact us to find out if this trial is right for you.
Contact
Amy Macke
650-723-0728
View on ClinicalTrials.gov
