Clinical trial · Interventional
Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases
Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Metastatic Liver Disease From Primary Colorectal, Neuroendocrine, Cholangiocarcinoma, Melanoma, and Breast Cancers Refractory to Chemotherapy: A Pilot Study
NCT01290536CI-TRIAL-00037390completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a prospective pilot study designed to document safety and efficacy of liver-directed therapy for colorectal, neuroendocrine, cholangiocarcinoma, melanoma, and breast cancer metastases to the liver using Yttrium-90 glass microspheres (TheraSphere).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Yttrium-90 liver radioembolization
- interventionNames
- Device: Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- 6 months
- description
- Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.
Secondary outcomes (1)
- measure
- Radiographic Response
- timeFrame
- 6 months after treatment
- description
- Radiographic response of treated lesions on cross-sectional imaging (computed tomography or magnetic resonance imaging) following treatment with Yttrium-90 glass microspheres (TheraSphere) was assessed based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no change in target lesions; Progressive Disease (PD), increase in target lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of metastatic colorectal, neuroendocrine, cholangiocarcinoma, melanoma, or breast malignancy 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. Concurrent therapy with octreotide is permitted, when appropriate. * 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 deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition. * 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.