Clinical trial · Observational
HDE Use Protocol of TheraSphere for Treatment of Unresectable HCC
A Humanitarian Device Exemption (HDE) Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
MDS Nordion's TheraSphere, Yttrium-90 glass microspheres has been approved as a Humanitarian device authorized by federal(USA)law for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma(HCC)who can have placement of appropriately positioned hepatic arterial catheters. Outcomes of this treatment protocol will be monitored and reported to the Carolinas HealthCare System Institutional Review Board.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TheraSphere-Yttrium 90 microsphere | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients enrolled
- description
- Total number of patients enrolled
- interventionNames
- Radiation: TheraSphere-Yttrium 90 microsphere
Primary outcomes (1)
- measure
- Progression
- timeFrame
- 6 months
- description
- Progression of liver cancer
Secondary outcomes (1)
- measure
- Number of Participants With Unacceptable Side Effects After Treatment
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of intrahepatic carcinoma. 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 alpha feta protein (AFP) markers (clinical diagnosis). * The cancer must be unresectable. * Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2 * Age greater than or equal to 18 * Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: * Any pre-treatment lab findings within 15 days of treatment demonstrating: absolute granulocyte count less than or equal to 1,500/ul, platelet count less than or equal to 45,000/ul, serum creatinine greater than or equal to 3.0 mg/dl, serum bilirubin greater than or equal to 4.0 mg/dl * Any of the following contraindications to angiography and selective visceral catheterization: history of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine; bleeding diathesis, not correctable by usual forms of therapy; severe peripheral vascular disease that would preclude catheterization * Portal hypertension with portal venous shunt away from the liver * Evidence of potential delivery of greater than 16.5 milliCurie (mCi) or 30 gray (Gy) absorbed dose of radiation to the lungs on either 1) first TheraSphere administration or 2) cumulative delivery of radiation to the lungs \> 30 Gy over multiple treatments. * Evidence of any detectable Tc-99m microaggregate albumin (MAA) flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow. * Significant extrahepatic disease representing an imminent life-threatening outcome * Severe liver dysfunction or pulmonary insufficiency * Active uncontrolled infection * Significant underlying medical or psychiatric illness. * Pregnant women may not participate.
References
Publications (0)
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