NCT00906984

Brief Summary

The purpose of this protocol is to provide TheraSphere treatment for patients with liver cancer who cannot be treated by surgery. The effect on the tumor and any side effects of TheraSphere treatment will be examined. This study will provide supervised and limited access to TheraSphere treatment at University California Irvine Medical Center. TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. When Y-90 is incorporated into very tiny glass beads (TheraSphere), it can be injected to the liver through blood vessels supplying the liver. This allows a large dose of radiation to be delivered to the tumor with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue. The radiation from TheraSphere is contained within the body and becomes minimally active within 7 days after treatment due to physical decay. The glass beads remain in the body, but do not cause any health problems. TheraSphere has been approved for use in the treatment of liver cancer in the United States by the Food and Drug Administration on a limited basis.

Trial Health

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Trial Health Score

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Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2007

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

First QC Date

December 27, 2007

Last Update Submit

January 4, 2024

Conditions

Hepatocellular CarcinomaLiver CancerLiver NeoplasmPrimary Liver Cancer

Keywords

Hepatocellular carcinomaLiver cancerPrimary liver cancerUnresectable liver cancerUnresectable hepatocellular carcinomaTheraSphere

Interventions

TheraSphereDEVICE

Given IV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of intrahepatic carcinoma. 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 assay (AFP) (clinical diagnosis).
  • The cancer must be unresectable.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2
  • Age ≥ 18 years.
  • Able to comprehend and read the study information sheet in accordance with institutional and federal guidelines.

You may not qualify if:

  • Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
  • Absolute granulocyte count ≤ 1,500/ul
  • Platelet count ≤ 75,000/μl
  • Serum creatinine ≥ 2.0 mg/dl
  • Serum bilirubin ≥ 2.0 mg/dl
  • Any of the following contraindications to angiography and selective visceral catheterization:
  • History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
  • Bleeding diathesis, not correctable by usual forms of therapy
  • 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 millicurie (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 or pulmonary insufficiency.
  • Active uncontrolled infection.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Related Publications (3)

  • Salem R, Thurston KG. Radioembolization with 90Yttrium microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies. Part 1: Technical and methodologic considerations. J Vasc Interv Radiol. 2006 Aug;17(8):1251-78. doi: 10.1097/01.RVI.0000233785.75257.9A.

    PMID: 16923973BACKGROUND

  • Salem R, Thurston KG. Radioembolization with 90yttrium microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies. Part 2: special topics. J Vasc Interv Radiol. 2006 Sep;17(9):1425-39. doi: 10.1097/01.RVI.0000235779.88652.53.

    PMID: 16990462BACKGROUND

  • Salem R, Thurston KG. Radioembolization with yttrium-90 microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies: part 3: comprehensive literature review and future direction. J Vasc Interv Radiol. 2006 Oct;17(10):1571-93. doi: 10.1097/01.RVI.0000236744.34720.73.

    PMID: 17056999BACKGROUND

Related Links

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Nadine Abi-Jaoudeh, MD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Radiology

Study Record Dates

First Submitted

December 27, 2007

First Posted

May 21, 2009

Last Updated

January 8, 2024

Record last verified: 2024-01

Locations

US(1)