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

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ClinicalTrials.gov Identifier: NCT02072356
Recruitment Status : Unknown
Verified March 2015 by Hooman Khabiri, Ohio State University Comprehensive Cancer Center.
Recruitment status was:  Recruiting
First Posted : February 26, 2014
Last Update Posted : March 27, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma
Study Start Date : October 2010
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Yttrium
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072356

Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Hooman Khabiri, MD 614-293-9508 Hooman.Khabiri@osumc.edu

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    Hooman.Khabiri@osumc.edu   
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
ClinicalTrials.gov Identifier: NCT02072356     History of Changes
Other Study ID Numbers: OSU-10036
NCI-2012-00877 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: March 27, 2015
Last Verified: March 2015

Keywords provided by Hooman Khabiri, 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