Trial record 68 of 3555 for:    Louisville | ( Map: United States )

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

Brief Summary:
The purpose of this protocol is to provide access to Therasphere treatment for patients with liver tumors.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Radiation: TheraSphere HUD Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TheraSphere HUD For Treatment of Unresectable HCC
Study Start Date : January 2004
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: TheraSphere
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

Primary Outcome Measures :
  1. Tumor Response after treatment [ Time Frame: Review all standard of care CT scans to evaluate tumor response after treatment ]

Secondary Outcome Measures :
  1. Incidence of toxicities / Adverse Events [ Time Frame: Monitor for toxicities to Therasphere ]
  2. Evaluate survival time [ Time Frame: life long ]
  3. Determine proportion of patients with HCC that can be treated with Therasphere [ Time Frame: at screening ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00683631

United States, Kentucky
University of Louisville Hospital / Norton Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
MDS Pharma Services
Principal Investigator: Robert C. Martin, MD University of Louisville

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Robert C. Martin, Professor of Surgery, University of Louisville Identifier: NCT00683631     History of Changes
Other Study ID Numbers: TheraSphere - 421.03
First Posted: May 23, 2008    Key Record Dates
Last Update Posted: October 21, 2013
Last Verified: October 2013

Keywords provided by Robert C. Martin, University of Louisville:
liver cancer
liver tumor
hepatocellular carcinoma

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