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Therasphere for Unresectable Primary or Secondary Liver Neoplasia

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
No longer available
CT.gov ID
NCT02960620
Collaborator
Biocompatibles UK Ltd (Industry), BTG International Inc. (Other)
1
Location

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: TheraSphere Treatment

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612

    Sponsors and Collaborators

    • H. Lee Moffitt Cancer Center and Research Institute
    • Biocompatibles UK Ltd
    • BTG International Inc.

    Investigators

    • Principal Investigator: Junsung Choi, M.D., H. Lee Moffitt Cancer Center and Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    H. Lee Moffitt Cancer Center and Research Institute
    ClinicalTrials.gov Identifier:
    NCT02960620
    Other Study ID Numbers:
    • MCC-15789
    First Posted:
    Nov 9, 2016
    Last Update Posted:
    Apr 19, 2022
    Last Verified:
    Apr 1, 2022
    Keywords provided by H. Lee Moffitt Cancer Center and Research Institute
    Humanitarian Device Exemption
    Liver Disease
    HDE #980006
    Additional relevant MeSH terms:
    Liver Neoplasms

    Study Results

    No Results Posted as of Apr 19, 2022