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No longer availableNCT00589030Updated Feb 15, 2017

Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

An expanded access record providing brachytherapy and yttrium Y 90 glass microspheres in Liver Cancer, sponsored by City of Hope Medical Center. No longer available at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-15.

Sponsored by City of Hope Medical Center · Expanded access

Study type
Expanded access
Ages
18 Years and older
Sex
All
01

Study 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: To provide expanded access and study the side effects of yttrium Y 90 glass microspheres in treating patients with liver cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with primary cancer to the liver and who are not surgical resection candidates.
  • Evaluate patient experience and toxicities associated with TheraSphere® treatment.
  • Enter treatment experience into a liver database.

Secondary

  • Determine the tumor response rates in patients receiving this treatment.

OUTLINE: This is a humanitarian device exemption use study.

Patients receive yttrium Y 90 glass microspheres (TheraSphere®) via percutaneous hepatic arterial infusion. Patients may be retreated between 30-90 days after the initial infusion.

After completion of study therapy, patients are followed for 30 days and then annually thereafter for up to 2 years.

02

Conditions studied

  • Liver Cancer

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Keywords

  • adult primary hepatocellular carcinoma
  • advanced adult primary liver cancer
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

Browse Liver Neoplasms studies →

Lead sponsor

City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Confirmed diagnosis of hepatocellular carcinoma
  • Surgical evaluation by a member of the Liver Tumor Program must conclude the patient is not a candidate for resection or ablation
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2
  • Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines

Exclusion criteria

Exclusion Criteria:

  • Absolute granulocyte count =\<1,500/ul
  • Platelet count =\<75,000/ul
  • Serum creatinine >= 2.0 mg/dl
  • Serum bilirubin

    • >= 2.0 mg/dl for bilateral treatment or lobar treatment
    • >= 3.0 mg/dl for single lesion which could be treated by segmental fusion
  • 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 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 MMA 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
05

Access details

Study type
Expanded access

Available treatment

  • Radiationbrachytherapy

    The target dose of TheraSphere® is 80-150Gy

  • Radiationyttrium Y 90 glass microspheres

    The target dose of TheraSphere® is 80-150Gy

06

Where to request access

1 site
  • City of Hope Medical Center
    Duarte, California 91010-3000, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00589030
Lead sponsor
City of Hope Medical Center
Responsible party
Sponsor
First posted
Jan 9, 2008
Start date
Apr 2007
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Feb 15, 2017

Study contacts

Yi-Jen Chen, MD, PhD
principal investigator · City of Hope Medical Center
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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