Clinical trial · Interventional
Yttrium-90 Radioembolization With Glass Microspheres (TheraSphere) for Patients With Hepatocellular Carcinoma
Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Hepatocellular Carcinoma: A Pilot Study
NCT01290523CI-TRIAL-00038572terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Off study clinical use of Y90 glass microspheres (TheraSphere)
Summary
Brief summary (as posted)
This is a prospective pilot study that will document the clinical experience of 30 patients with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere®).
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 |
|---|---|---|---|
| Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Yttrium-90 liver radioembolization
- description
- Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)
- interventionNames
- Device: Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere)
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- 6 months
- description
- Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain
Secondary outcomes (1)
- measure
- Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of hepatocellular carcinoma with liver-dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria. * The cancer is unresectable. * All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Age 18 years or older. * Able to understand informed consent. Exclusion Criteria: * Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: * single TheraSphere administration; or * cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments. * Evidence of any detectable Tc-99m macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow. * Previous radiation therapy to the lungs and/or to the upper abdomen * Pregnancy * Symptomatic lung disease. * Significant extrahepatic disease representing an imminent life-threatening outcome. * Active uncontrolled infection * Any pre-treatment laboratory findings within 30 days of treatment demonstrating: * Aspartate or alanine aminotransferase level greater than 5 times upper normal limit. * Serum bilirubin greater than 2 mg/dl * Infiltrative tumor on imaging * Tumor volume greater than 70% of liver volume * Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL
References
Publications (0)
Data not yet available
No reference posted for this study.