TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)

NCT00683631 | Completed DMC

• 1 other identifier: TheraSphere - 421.03
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Keywords

liver cancer; liver tumor; HCC; hepatocellular carcinoma; hepatoma

Study Arms (1)

TheraSphere

TheraSphere

Other: TheraSphere HUD

Interventions

TheraSphere HUD 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.

Also known as: TheraSphere HDE # 980006

TheraSphere

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is an observational treatment use protocol that will provide IRB oversight and documentation of the clinical experience of patients undergoing treatment for primary or secondary liver neoplasia using TheraSphere® under an HDE. Participation involves no investigational or research procedures. Patients will be followed for treatment-related adverse experiences for a minimum of 30 days after each treatment. Survival experience will be monitored in accordance with institutional practices.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• MDS Pharma Services: collaborator

Study Sites (1)

University of Louisville Hospital / Norton Hospital

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• 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.

  PMID: 19317999 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Robert C. Martin, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 23, 2008
• Study Start: January 1, 2004
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: December 18, 2023

Record last verified: 2021-12

Locations

US (1)