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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 Daniel Yung-Ho Sze, Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01076517
First Posted: February 26, 2010
Last Update Posted: October 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
BTG International Inc.
Information provided by (Responsible Party):
Daniel Yung-Ho Sze, Stanford University
  Purpose
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 Daniel Yung-Ho Sze, 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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 </= 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076517


Contacts
Contact: Danielle Katz 650-723-0728 dkatz@stanfordhealthcare.org

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Contact: Danielle Katz    650-723-0728    dkatz@stanfordhealthcare.org   
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.
Investigators
Principal Investigator: Daniel Yung-Ho Sze Stanford University
  More Information

Responsible Party: Daniel Yung-Ho Sze, Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT01076517     History of Changes
Other Study ID Numbers: XHEP0016-NOT-RESEARCH
HEP0016 ( Other Identifier: Stanford University )
14324 ( Other Identifier: Stanford IRB )
First Submitted: February 24, 2010
First Posted: February 26, 2010
Last Update Posted: October 17, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases


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