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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TheraSphere HUD
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring liver cancer, liver tumor, HCC, hepatocellular carcinoma, hepatoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Louisville Hospital / Norton Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TheraSphere

Arm Description

TheraSphere

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 16, 2008
Last Updated
December 12, 2021
Sponsor
University of Louisville
Collaborators
MDS Pharma Services
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1. Study Identification

Unique Protocol Identification Number
NCT00683631
Brief Title
TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Acronym
TheraSphere
Official Title
TheraSphere HUD For Treatment of Unresectable HCC
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 2004 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
MDS Pharma Services

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
liver cancer, liver tumor, HCC, hepatocellular carcinoma, hepatoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TheraSphere
Arm Type
Experimental
Arm Description
TheraSphere
Intervention Type
Radiation
Intervention Name(s)
TheraSphere HUD
Other Intervention Name(s)
TheraSphere HDE # 980006
Intervention Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert C. Martin, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville Hospital / Norton Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19317999
Citation
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.
Results Reference
derived

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TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)

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