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TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)

NCT ID: NCT00683631

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

183 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2021-04-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Keywords

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liver cancer liver tumor HCC hepatocellular carcinoma hepatoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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TheraSphere

TheraSphere

TheraSphere HUD

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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TheraSphere HDE # 980006

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MDS Pharma Services

INDUSTRY

Sponsor Role collaborator

University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Robert C. Martin

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert C. Martin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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University of Louisville Hospital / Norton Hospital

Louisville, Kentucky, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 19317999 (View on PubMed)

Other Identifiers

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TheraSphere - 421.03

Identifier Type: -

Identifier Source: org_study_id