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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00532740
Recruitment Status : Recruiting
First Posted : September 20, 2007
Last Update Posted : June 4, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

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 how well radiolabeled glass beads work in treating patients with metastatic liver cancer that cannot be removed by surgery.

Condition or disease Intervention/treatment
Liver Cancer Metastatic Cancer Radiation: Yttrium Y 90 glass microspheres

Detailed Description:


  • Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients who are not candidates for surgical resection of metastatic intrahepatic carcinoma.
  • Evaluate patient experience and toxicities associated with yttrium Y 90 glass microspheres treatment.

OUTLINE: This is a humanitarian device exemption use study.

Patients receive yttrium Y 90 glass microspheres (TheraSphere®) into the liver tumor through a percutaneously placed catheter into the hepatic artery. Patients may receive additional therapy 4-12 weeks after initial treatment at the discretion of the study physician.

After completion of study therapy, patients are followed at 2 weeks, 30 days, and then once a year for approximately 2 years.

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver
Study Start Date : December 2004
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Yttrium

Group/Cohort Intervention/treatment
All Patients
Patients with metastatic cancer of the liver who are not surgical resection candidates and who will be treated with TheraSphere per institutional standard of care.
Radiation: Yttrium Y 90 glass microspheres
Between 0.2 to 0.5 Curies (200-500-mCi), either single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart per treating physician's discretion.

Primary Outcome Measures :
  1. Patient experience and toxicity associated with TheraSphere® treatment [ Time Frame: During & at completion of treatment. ]
    Evaluate patient experience and toxicities associated with TheraSphere® treatment.

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.

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 with metastatic cancer of the liver who are not surgical resection candidates.


  • Confirmed diagnosis of metastatic intrahepatic carcinoma

    • Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass AND known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP
  • Unresectable disease
  • No portal hypertension with portal venous shunt away from the liver
  • FDA approval to receive compassionate use of yttrium Y 90 glass microspheres
  • No significant extrahepatic disease representing an imminent life-threatening outcome
  • No evidence of potential delivery of > 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either of the following:

    • First administration of yttrium Y 90 glass microspheres (TheraSphere ®)
    • Cumulative delivery of radiotherapy to the lungs over multiple treatments


  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute granulocyte count ≥ 1,500/µL
  • Platelet count ≥ 25,000/μL
  • Creatinine ≤ 2.0 mg/dL (unless using non-iodinated contrast or on dialysis)
  • Serum bilirubin ≤ 3.0 mg/dL (in some cases where there is an elevated bilirubin, and the tumor may be isolated from a vascular standpoint, treatment may proceed)
  • No contraindication to angiography or selective visceral catheterization, including any of the following:

    • History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, that cannot be controlled using basic angiographic techniques
    • Bleeding diathesis, not correctable by usual forms of therapy
    • Severe peripheral vascular disease that would preclude catheterization
  • No severe liver dysfunction or pulmonary insufficiency
  • No active uncontrolled infection
  • No significant underlying medical or psychiatric illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No evidence of any detectable technetium-99 macroaggregated albumin (Tc-99 MAA) flow to the stomach or duodenum after application of established angiographic techniques to stop such flow
  • No comorbid disease or condition that would preclude safe delivery of yttrium Y 90 glass microspheres and place patient at undue risk


  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy
  • More than 2 weeks since prior surgery
  • At least 2 weeks since prior radiosensitizing chemotherapy
  • More than 6 weeks since prior carmustine (BCNU) or mitomycin C
  • No other concurrent cancer therapy

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): NCT00532740

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer    312-695-1301   
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Study Chair: Riad Salem, MD Robert H. Lurie Cancer Center

Publications of Results:
Responsible Party: Northwestern University Identifier: NCT00532740     History of Changes
Other Study ID Numbers: NU 1365-002
P30CA060553 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2007    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018

Keywords provided by Northwestern University:
liver metastases
advanced adult primary liver cancer

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes
Liver Extracts