TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC) (TheraSphere)

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. Read our disclaimer for details. Identifier: NCT00683631
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : October 21, 2013
MDS Pharma Services
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville

May 16, 2008
May 23, 2008
October 21, 2013
January 2004
July 2012   (Final data collection date for primary outcome measure)
Tumor Response after treatment [ Time Frame: Review all standard of care CT scans to evaluate tumor response after treatment ]
Same as current
Complete list of historical versions of study NCT00683631 on Archive Site
  • Incidence of toxicities / Adverse Events [ Time Frame: Monitor for toxicities to Therasphere ]
  • Evaluate survival time [ Time Frame: life long ]
  • Determine proportion of patients with HCC that can be treated with Therasphere [ Time Frame: at screening ]
Same as current
Not Provided
Not Provided
TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)
TheraSphere HUD For Treatment of Unresectable HCC
The purpose of this protocol is to provide access to Therasphere treatment for patients with liver tumors.
Surgical resection of the affected portion of the liver offers the best chance for disease-free survival in patients with primary liver cancer (hepatocellular carcinoma (HCC)). Unfortunately, most of these patients present with disease that is not amenable to surgery (multifocal disease) or have other medical contraindications to surgery (limited hepatic reserve related to advanced cirrhosis or chronic hepatitis). Fewer than 15% of HCC patients are suitable surgical candidates. The objective of treatment with TheraSphere is to selectively administer a potentially lethal dose of radioactive material to cancerous tissue in the liver of patients with HCC. This type of regional therapy may have several advantages over systemically administered treatments and may also be of value as a 'bridging' treatment for HCC patients awaiting a donor organ for liver transplantation.
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatocellular Carcinoma
Radiation: TheraSphere HUD
TheraSphere is FDA approved under a Humanitarian Use Device. It is considered a brachytherapy device that delivers intra-arterial radiation therapy using yttrium-90 microspheres directly to liver tumors.
Other Name: TheraSphere HDE # 980006
Experimental: TheraSphere
Intervention: Radiation: TheraSphere HUD
Woodall CE, Scoggins CR, Ellis SF, Tatum CM, Hahl MJ, Ravindra KV, McMasters KM, Martin RC 2nd. Is selective internal radioembolization safe and effective for patients with inoperable hepatocellular carcinoma and venous thrombosis? J Am Coll Surg. 2009 Mar;208(3):375-82. doi: 10.1016/j.jamcollsurg.2008.12.009.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2012
July 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients over 18 years of age, of any race or sex, who have histologic proof of primary cancer to the liver, who are able to give informed consent, will be eligible.
  • Patients must have an ECOG Performance Status score of greater than or equal to 2, with a life expectancy of > 3 months, non-pregnant with an acceptable contraception in premenopausal women.
  • The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP (clinical diagnosis).
  • Participation in the TheraSphere Registry.

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-99 MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
  • Significant extrahepatic disease representing an imminent life-threatening outcome
  • Severe liver dysfunction or pulmonary insufficiency
  • Active uncontrolled infection
  • Pregnancy
  • Refusal to participate in the TheraSphere Registry
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
TheraSphere - 421.03
Not Provided
Not Provided
Robert C. Martin, University of Louisville
University of Louisville
MDS Pharma Services
Principal Investigator: Robert C. Martin, MD University of Louisville
University of Louisville
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP