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

NCT01290523 | Terminated Results DMC

• 1 other identifier: UCSF-SIRT-HCC
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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®).

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain

  6 months

Secondary Outcomes (1)

• Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  6 months

Study Arms (1)

Yttrium-90 liver radioembolization

EXPERIMENTAL

Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)

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

Interventions

Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere) DEVICE

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

Yttrium-90 liver radioembolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Dr Nicholas Fidelman
• Organization: University of California San Francisco Department of Radiology

Nicholas.Fidelman@ucsf.edu

(415) 353-1300

Study Officials

• Nicholas Fidelman, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 7, 2011
• Study Start: May 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 13, 2019
• Results First Posted: August 25, 2015

Record last verified: 2019-04

Locations

US (1)