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Therasphere for Unresectable Primary or Secondary Liver Neoplasia

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ClinicalTrials.gov Identifier: NCT02960620
Expanded Access Status : Available
First Posted : November 9, 2016
Last Update Posted : February 3, 2021
Sponsor:
Collaborators:
Biocompatibles UK Ltd
BTG International Inc.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Description
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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
Liver Cancer Liver Neoplasms HepatoCellular Carcinoma Device: TheraSphere Treatment

Study Design
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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

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • 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.
Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960620


Contacts
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Contact: Junsung Choi, M.D. 813-745-4615 junsung.choi@moffitt.org

Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Available
Tampa, Florida, United States, 33612
Principal Investigator: Jungsung Choi, M.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Biocompatibles UK Ltd
BTG International Inc.
Investigators
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Principal Investigator: Junsung Choi, M.D. H. Lee Moffitt Cancer Center and Research Institute
More Information
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Additional Information:

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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02960620    
Other Study ID Numbers: MCC-15789
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Humanitarian Device Exemption
Liver Disease
HDE #980006
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases