Working… Menu
Trial record 1 of 1 for:    NCT01290536
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01290536
Recruitment Status : Completed
First Posted : February 7, 2011
Results First Posted : December 22, 2014
Last Update Posted : March 1, 2019
Information provided by (Responsible Party):
Nicholas Fidelman, MD, University of California, San Francisco

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).

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Neuroendocrine Tumors Cholangiocarcinoma Melanoma Breast Cancer Device: Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: Yttrium-90 liver radioembolization Device: Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)
Administration of Yttrium-90 glass microspheres (TheraSphere) into the hepatic artery

Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 6 months ]
    Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.

Secondary Outcome Measures :
  1. Radiographic Response [ Time Frame: 6 months after treatment ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Layout table for additonal information
Responsible Party: Nicholas Fidelman, MD, Principal Investigator, University of California, San Francisco Identifier: NCT01290536     History of Changes
Other Study ID Numbers: UCSF-SIRT-Metastases
First Posted: February 7, 2011    Key Record Dates
Results First Posted: December 22, 2014
Last Update Posted: March 1, 2019
Last Verified: February 2019
Keywords provided by Nicholas Fidelman, MD, University of California, San Francisco:
Liver metastases
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neuroendocrine Tumors
Colorectal Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Glandular and Epithelial
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Extracts
Central Nervous System Stimulants
Physiological Effects of Drugs