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Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT00039078
Recruitment Status : Withdrawn (Record created in error - not a research study)
First Posted : January 27, 2003
Last Update Posted : June 26, 2017
Information provided by (Responsible Party):
Allan Tsung, University of Pittsburgh

Brief Summary:

RATIONALE: 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 effective treatment for liver cancer that cannot be removed by surgery.

PURPOSE: This phase II trial is studying the side effects of hepatic arterial infusion using yttrium-90 microspheres (TheraSphere®) to see how well it works in treating patients with liver cancer that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Liver Cancer Radiation: yttrium Y 90 glass microspheres Phase 2

Detailed Description:


  • Provide supervised access to yttrium-90 glass microspheres (TheraSphere®) for patients with unresectable hepatocellular carcinoma.
  • Determine the response in patients with unresectable hepatocellular carcinoma treated with hepatic arterial infusion of yttrium-90 glass microspheres.
  • Determine the toxic effects and adverse experiences associated with this therapy in these patients.
  • Determine the survival time of patients treated with this therapy.
  • Determine the time to progression of disease in the liver, duration of response, and progression-free interval of patients treated with this therapy.
  • Evaluate the influence of pretreatment characteristics on efficacy parameters in patients treated with this therapy.
  • Assess the quality of life of patients treated with this therapy.

OUTLINE: Radioactive material yttrium-90 glass microspheres (TheraSphere®) is infused directly into a liver tumor in order to kill tumor cells and cause less damage to the normal tissue. Patients receive TheraSphere® via hepatic arterial infusion on day 1. This artery is accessed through the femoral artery in the groin. This procedure is generally completed on an outpatient basis. Patients may receive a single dose to the whole liver, or sequential treatments to each side of the liver approximately 30 to 90 days apart. Patients may be re-treated at a later time.

Patients are followed every 2 to 4 months for the rest of their lives to access tumor progression, symptom management and quality of life.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma
Study Start Date : August 2000
Estimated Primary Completion Date : August 2000
Estimated Study Completion Date : August 2000

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Response to treatment
  2. Survival time from treatment
  3. Adverse experiences

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Confirmed diagnosis of hepatocellular carcinoma (HCC)

    • Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass in addition to known laboratory or clinical risk factors for HCC, and/or an elevated alpha-fetoprotein (AFP) level
  • No significant extrahepatic disease that may represent an imminent life-threatening outcome
  • No evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiotherapy to the lungs on either the first yttrium-90 glass microspheres (TheraSphere®) administration or with cumulative delivery of radiation to the lungs over multiple treatments due to any angiographically uncorrectable flow to the gastrointestinal tract


  • ECOG performance status 0-2
  • No hepatic dysfunction
  • Bilirubin ≤ 2.0 mg/dL
  • No vascular abnormalities or severe peripheral vascular disease that would preclude angiography or selective visceral catheterization
  • No pulmonary insufficiency
  • No evidence of detectable technetium Tc 99m macroaggregates of albumin flow to the stomach or duodenum after application of established angiographic techniques to stop such flow
  • No contraindications to angiography
  • No contraindications to selective visceral catheterization
  • No other condition or cormorbidity that would preclude study treatment
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 30 days after study


  • At least 1 month since prior chemotherapy, radiotherapy, or surgery
  • No other concurrent investigational agents or anticancer therapy for HCC

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): NCT00039078

United States, Pennsylvania
UPMC Liver Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Allan Tsung
Study Chair: T. Clark Gamblin, MD UPMC Cancer Center at UPMC Presbyterian

Responsible Party: Allan Tsung, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00039078     History of Changes
Other Study ID Numbers: PCI-IRB-0611014
CDR0000069336 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Allan Tsung, University of Pittsburgh:
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
adult primary 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