TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma Clinical Trial

— TheraSphere  

Official title:

TheraSphere HUD For Treatment of Unresectable HCC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683631
• Other study ID #: TheraSphere - 421.03
• Status: Completed
• Start date: January 2004
• Est. completion date: April 1, 2021

Study information

• Verified date: December 2021
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Louisville Hospital / Norton Hospital	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	MDS Pharma Services

Country where clinical trial is conducted

United States,