Therasphere for Unresectable Primary or Secondary Liver Neoplasia



Status:Available
Conditions:Liver Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Contact:Junsung Choi, M.D.
Email:junsung.choi@moffitt.org
Phone:813-745-4615

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

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


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
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Jungsung Choi, M.D.
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Tampa, FL
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