Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Colorectal Neoplasms, Neuroendocrine Tumors, Cholangiocarcinoma, Melanoma, Breast Cancer

Intervention / Treatment
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* Device: Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yttrium-90 liver radioembolization<br> | Device: Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)<br>* Administration of Yttrium-90 glass microspheres (TheraSphere) into the hepatic artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Response | 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. | 6 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver metastases