Yttrium-90 Radioembolization With Glass Microspheres (TheraSphere) for Patients With Hepatocellular Carcinoma

Stopped early · Not applicable

Conditions studied: Hepatocellular Carcinoma

In brief

This is a prospective pilot study that will document the clinical experience of 30 patients with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere®).

Key facts

Study ID

NCT01290523

Run by

University of California, San Francisco

People needed

14

Starts

2010-05-01

Expected to finish

2014-05-01

Last updated by the study team

2019-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of hepatocellular carcinoma 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Age 18 years or older.
• Able to understand informed consent.

You may not qualify if…

• 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 flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
• 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

Where it is running

• University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.