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

Trial ID or NCT#

NCT01076517

Status

not recruiting iconNOT 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:
  1. 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:
  1. - 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)

Daniel Sze, MD, PhD
Daniel Sze, MD, PhD
Interventional radiologist
Professor of Radiology (Interventional Radiology)
David S. Wang, MD
Interventional radiologist, Radiologist, Minimally invasive surgeon, Diagnostic radiologist
Clinical Associate Professor, Radiology
Andrew Picel
Andrew Picel
Interventional radiologist
Clinical Associate Professor, Radiology
John D. Louie, MD
John D. Louie, MD
Interventional radiologist
Clinical Professor, Radiology
Nishita Kothary, MD
Nishita Kothary, MD
Interventional radiologist
Professor of Radiology (Interventional Radiology)

Contact us to find out if this trial is right for you.

Contact

Amy Macke
650-723-0728