Brief Title
Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases
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
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).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants With Adverse Events
Secondary Outcome
Radiographic Response
Condition
Colorectal Neoplasms
Intervention
Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)
Study Arms / Comparison Groups
Yttrium-90 liver radioembolization
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
42
Start Date
May 2010
Completion Date
October 2013
Primary Completion Date
October 2013
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Administrative Informations
NCT ID
NCT01290536
Organization ID
UCSF-SIRT-Metastases
Responsible Party
Sponsor-Investigator
Study Sponsor
Nicholas Fidelman, MD
Study Sponsor
, ,
Verification Date
February 2019