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A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00877136
Recruitment Status : Unknown
Verified October 2014 by St. Joseph Hospital of Orange.
Recruitment status was:  Recruiting
First Posted : April 7, 2009
Last Update Posted : October 16, 2014
Information provided by (Responsible Party):
St. Joseph Hospital of Orange

Brief Summary:

This is an interdisciplinary study that falls into the Humanitarian Use Device category. There are no hypotheses to be tested in this treatment protocol. The study has the following objectives:

  1. Provide supervised access to treatment with TheraSphere® to eligible patients with primary cancer to the liver who are not surgical resection candidates.
  2. Evaluate patient experience and toxicities associated with TheraSphere® treatment.
  3. Measure tumor response rates

Condition or disease Intervention/treatment
Liver Tumors Hepatocellular Carcinoma Hepatoma Neoplasms Device: TheraSphere®

Detailed Description:
The purpose of this protocol is to provide supervised access at this institution to TheraSphere® treatment for a heterogeneous population of patients with unresectable primary liver tumors, with the liver being the only dominant site of disease. Based on experience gained in previous studies and well-established interventional radiology techniques, this protocol allows multiple treatments with TheraSphere® that may be delivered on an inpatient or out patient basis. Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 - 90 days apart. The investigator, working with co-investigators in radiation oncology, interventional radiology and nuclear medicine, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy, and the desired goal of treatment.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere®
Study Start Date : February 2009
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: TheraSphere®
    TheraSphere® consists of insoluble glass microspheres where yttrium-90 is an integral constituent of the glass. TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. This artery provides the main blood supply to the tumor in the liver. TheraSphere® being unable to traverse the tumor vasculature is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue.

Primary Outcome Measures :
  1. Evaluate patient quality of life and toxicities associated with TheraSphere® treatment [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Tumor response to treatment with TheraSphere® [ Time Frame: 24 Months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from St. Joseph Hospital of Orange, community members in the St. Joseph Hospital service area and surrounding areas

Inclusion Criteria:

  • Confirmed diagnosis of hepatocellular carcinoma. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass with known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP (clinical diagnosis)
  • Surgical evaluation must conclude the patient is not a candidate for resection or ablation.
  • ECOG Performance Status Score 0 - 2.
  • Age 18 years or older.
  • Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

Any pre-treatment laboratory findings within 15 days of treatment demonstrating:

  • Absolute granulocyte count less than or equal to 1,500/ul
  • Uncorrected Platelet count less than or equal to 75,000/ul
  • Serum creatinine greater than or equal to 3.0 mg/dl
  • Serum bilirubin greater than or equal to 2.0 mg/dl
  • Any of the following contraindications to angiography and selective visceral catheterization, 1.)History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, 2.) Bleeding diathesis, not correctable by usual forms of therapy, and/or 3.) Severe peripheral vascular disease that would preclude catheterization.
  • Portal hypertension with portal venous shunt away from the liver.
  • Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: 1) first TheraSphere® administration; or 2) cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments.
  • Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
  • Significant extrahepatic disease representing an imminent life-threatening outcome.
  • Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy).
  • Active uncontrolled infection
  • Significant underlying medical or psychiatric illness.
  • Pregnant women may not participate.
  • Children may not participate due to lack of clinical experience.

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 identifier (NCT number): NCT00877136

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Contact: Jessica Silvester 714-734-6220
Contact: Lavinia Dobrea 714-734-6220

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United States, California
The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange Recruiting
Orange, California, United States, 92868
Contact: Jessica Silvester    714-734-6220      
Contact: Gitana Davila    714-734-6220 ext 41477      
Principal Investigator: Lawrence Wagman, M.D., F.A.C.S.         
Sub-Investigator: Robert Ash, MD         
Sub-Investigator: Afshin Forouzannia, MD         
Sub-Investigator: Judith Harrison-Monge, MD         
Sub-Investigator: Timothy Byun, MD         
Sub-Investigator: Hisham El-Bayar, MD         
Sub-Investigator: Kurt Openshaw, MD         
Sub-Investigator: Mahmood Razavi, MD         
Sponsors and Collaborators
St. Joseph Hospital of Orange
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Principal Investigator: Lawrence Wagman, M.D., F.A.C.S. St. Joseph Hospital of Orange
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Responsible Party: St. Joseph Hospital of Orange Identifier: NCT00877136    
Other Study ID Numbers: 08-029 TheraSphere®
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014
Keywords provided by St. Joseph Hospital of Orange:
Liver tumors
Liver cancer
Adult primary hepatocellular carcinoma
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases