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

Nicholas Fidelman, MD

Status and phase: Completed; Phase 2

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01290536

UCSF-SIRT-Metastases

Details and patient eligibility

About

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).

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Yttrium-90 liver radioembolization

Experimental group

Treatment:

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