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NCT02960620 Clinical Trial

Therasphere for Unresectable Primary or Secondary Liver Neoplasia

HepatoCellular Carcinoma Clinical Trial

Official title:
A Humanitarian Device Exemption (HDE) Treatment Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Neoplasia - HDE #980006

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT02960620
Other study ID # MCC-15789
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date September 2022
Source H. Lee Moffitt Cancer Center and Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

This is not a research study. The purpose is to provide supervised access to TheraSphere® therapy at this institution.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients will be recruited from the patient population referred to the principal clinician for regional liver cancer therapy. - Potential candidates are those diagnosed with primary or secondary liver neoplasia. 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 and clinical findings. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing Hepatocellular Carcinoma (HCC). - Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2 - Life expectancy = 3 months - > 4 weeks since prior radiation, surgery or chemotherapy - Able to comprehend and provide consent in accordance with institutional and federal guidelines Exclusion Criteria: - Any other liver therapy planned for cancer treatment - Uncorrectable flow to the gastrointestinal tract - Estimated radiation doses to the lungs greater than 30 Gy in a single administration or 50 Gy in multiple administrations - Significant extrahepatic disease representing imminent life-threatening outcome - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• TheraSphere Treatment
TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. The hepatic artery provides the main blood supply to the tumor in the liver, whereas the portal vein supplies blood to normal liver parenchyma. TheraSphere® is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue.

Locations
Country Name City State
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida

Sponsors (3)
Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute Biocompatibles UK Ltd, BTG International Inc.

Country where clinical trial is conducted

United States, 

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