A Clinical Use Application for the Humanitarian Use Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Primary or Secondary Liver Neoplasia
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Eau Claire, Wisconsin: 14-007885
Sponsor Protocol Number: 14-007885
About this study
This protocol allows multiple treatments with TheraSphere® that may be delivered on an outpatient basis. Patients may receive a single dose to a liver lobe or segmental treatment delivered as a sequence of treatments approximately 30-90 days apart. The principal clinician, working with a multidisciplinary team, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy and the desired goal of treatment.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Diagnosis of 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 such as alphafetoprotein (AFP)2 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 HCC:
- ECOG Performance Status Score 0 - 2
- Age ≥18 years
- Life expectancy ≥3 months
- >4 weeks since prior radiation, surgery or chemotherapy
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
Patients may not be treated with TheraSphere® if they have any of the following exclusions:
- Any pre-treatment laboratory findings within 15 days of treatment demonstrating liver dysfunction:
- AST or ALT >5 times UNL
- For HCC: Serum bilirubin >2.0 mg/dl (unless segmental infusion is planned47)
- For other primary or secondary liver neoplasis, bilirubin levels will be determined to confirm suitability for TheraSphere®based on levels specific to the primary or secondary liver neoplasia being treated
- Any contraindications to angiography and hepatic artery catheterization such as:
- History of severe allergy or intolerance to any contrast media, narcotics, sedatives or atropine that cannot be corrected or premedicated
- Bleeding diathesis, not correctable by usual forms of therapy
- Severe peripheral vascular disease that would preclude catheterization.
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single injection, or greater than 50 Gy for multiple injections
- Evidence of pulmonary insufficiency
- Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow
- Significant extrahepatic disease representing an imminent life-threatening outcome
- Active uncontrolled infection
- Significant underlying medical or psychiatric illness
- Co-morbid disease or condition that would preclude safe delivery of TheraSphere® treatment or, in the judgment of the physician, place the patient at undue risk
- Special Categories of Patients: Not applicable
- Research in Mentally Disabled People: No.All participants or legal guardians will be fully able to give informed consent.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Eau Claire, Wis.
Mayo Clinic principal investigator
Jeremy McBride, M.D.
Contact us for the latest status
Jeremy McBride M.D.
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