Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Ohio State University Comprehensive Cancer Center.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Hooman Khabiri, Ohio State University Comprehensive Cancer Center Identifier:
First received: February 24, 2014
Last updated: March 25, 2015
Last verified: March 2015
This clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in treating patients with unresectable hepatocellular carcinoma. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be an effective treatment for liver cancer.

Condition Intervention
Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Radiation: yttrium Y 90 glass microspheres
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Response to treatment [ Time Frame: Up to 2 years ]
  • Survival time [ Time Frame: Up to 2 years ]
  • Adverse experiences [ Time Frame: Up to 2 years ]

Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (yttrium Y 90 glass microspheres)
Patients receive yttrium Y 90 glass microspheres IA on day 0. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.
Radiation: yttrium Y 90 glass microspheres
Given Interartrial
Other Name: TheraSphere
Other: laboratory biomarker analysis
Alpha-fetoprotein assay
Other Names:
  • Correlative studies
  • AFP

Detailed Description:


I. Provide oversight to treatment with TheraSphere to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates.

II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.


Patients receive yttrium Y 90 glass microspheres intra-arterially (IA) on day 0, and may receive a second dose within 30-90 days of initial treatment. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.

After completion of study treatment, patients are followed up at 3-6 weeks and annually for 2 years.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of intrahepatic malignancy including but not limited to HCC; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (AFP) and clinical findings
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
  • Life expectancy >= 3 months
  • > 4 weeks since prior radiation, surgery or chemotherapy
  • Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
  • Ineligible for surgical resection

Exclusion Criteria:

  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (UNL)
  • Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
  • Any contraindications to angiography and hepatic artery catheterization such as:

    • History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
    • Bleeding diathesis, not correctable by usual forms of therapy
    • Severe peripheral vascular disease that would preclude catheterization
  • Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
  • Evidence of pulmonary insufficiency
  • Evidence of any detectable technetium-99m macroaggregated serum albumin (Tc-99m MAA) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow
  • Significant extrahepatic disease representing an imminent life-threatening outcome
  • Active uncontrolled infection
  • Significant underlying medical or psychiatric illness
  • Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk
  • Pregnancy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02072356

Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066
Contact: Hooman Khabiri, MD 614-293-9508

United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Hooman Khabiri, MD    614-293-2773   
Principal Investigator: Hooman Khabiri, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Principal Investigator: Hooman Khabiri Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
Responsible Party: Hooman Khabiri, Principal Investigator, Ohio State University Comprehensive Cancer Center Identifier: NCT02072356     History of Changes
Other Study ID Numbers: OSU-10036
NCI-2012-00877 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: February 24, 2014
Last Updated: March 25, 2015

Keywords provided by Ohio State University Comprehensive Cancer Center:
Humanitarian Device
Hepatocellular Carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors processed this record on May 23, 2017