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

Expanded access is currently available for this treatment.
Verified October 2016 by Stanford University
BTG International Inc.
Information provided by (Responsible Party):
Daniel Yung-Ho Sze, Stanford University Identifier:
First received: February 24, 2010
Last updated: October 13, 2016
Last verified: October 2016
To provide Therasphere treatment for patients diagnosed with unresectable liver cancer.

Condition Intervention
Liver Cancer
Device: Theraspheres

Study Type: Expanded Access     What is Expanded Access?
Official Title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:

Further study details as provided by Stanford University:

Study Start Date: December 2008
Estimated Study Completion Date: December 2099
Estimated Primary Completion Date: December 2099 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Theraspheres
    Beta-emitting 90yttrium encapsulated in glass microspheres for intraarterial administration to the liver.
    Other Names:
    • HCC
    • hepatocellular carcinoma treatment

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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 </= 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01076517

Contact: Danielle Katz 650-723-0728

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Contact: Danielle Katz    650-723-0728   
Principal Investigator: Daniel Y Sze, MD PhD         
Sub-Investigator: John D Louie, MD         
Sub-Investigator: Nishita Kothary, MD         
Sub-Investigator: David Wang, MD         
Sponsors and Collaborators
Stanford University
BTG International Inc.
Principal Investigator: Daniel Yung-Ho Sze Stanford University
  More Information

Responsible Party: Daniel Yung-Ho Sze, Professor of Radiology, Stanford University Identifier: NCT01076517     History of Changes
Other Study ID Numbers: XHEP0016-NOT-RESEARCH  HEP0016  14324 
Study First Received: February 24, 2010
Last Updated: October 13, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on October 25, 2016