Therasphere for Unresectable Primary or Secondary Liver Neoplasia
Primary Purpose
Liver Cancer, Liver Neoplasms, HepatoCellular Carcinoma
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
TheraSphere Treatment
Sponsored by
About this trial
This is an expanded access trial for Liver Cancer focused on measuring Humanitarian Device Exemption, Liver Disease, HDE #980006
Eligibility 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
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02960620
First Posted
November 8, 2016
Last Updated
September 27, 2022
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Biocompatibles UK Ltd, BTG International Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02960620
Brief Title
Therasphere for Unresectable Primary or Secondary Liver Neoplasia
Official Title
A Humanitarian Device Exemption (HDE) Treatment Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Neoplasia - HDE #980006
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Biocompatibles UK Ltd, BTG International Inc.
4. Oversight
5. Study Description
Brief Summary
This is not a research study. The purpose is to provide supervised access to TheraSphere® therapy at this institution.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Liver Neoplasms, HepatoCellular Carcinoma
Keywords
Humanitarian Device Exemption, Liver Disease, HDE #980006
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
TheraSphere Treatment
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junsung Choi, M.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Links:
URL
https://moffitt.org/clinical-trials-research/
Description
Moffitt Cancer Center Clinical Trials website
Learn more about this trial
Therasphere for Unresectable Primary or Secondary Liver Neoplasia
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