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

NCT ID: NCT01290536

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-10-31

Brief Summary

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

Colorectal Neoplasms; Neuroendocrine Tumors; Cholangiocarcinoma; Melanoma; Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Yttrium-90 liver radioembolization

Group Type: EXPERIMENTAL

Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)

Intervention Type: DEVICE

Administration of Yttrium-90 glass microspheres (TheraSphere) into the hepatic artery

Interventions

Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)

Administration of Yttrium-90 glass microspheres (TheraSphere) into the hepatic artery

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nicholas Fidelman, MD

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Fidelman, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

UCSF-SIRT-Metastases

Identifier Type: -

Identifier Source: org_study_id