TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis

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: NCT01556282
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : May 28, 2014
Information provided by (Responsible Party):
Hyun Kevin Kim, Emory University

Brief Summary:
Therasphere will be administered via catheter through the Hepatic Artery to treat patients with Hepatocellular Carcinoma and Portal vein Thrombosis.

Condition or disease Intervention/treatment Phase
Liver Cancer Portal Vein Thrombosis Device: TheraSphere Not Applicable

Detailed Description:

Therasphere consists of glass microspheres containing a radioactive material called Yttrium-90.

Therasphere is delivered into the liver tumor through a catheter placed into the hepatic artery which is the artery that provides the main blood supply to the tumor, this way delivering the radioactive material directly to the tumor and sparing the rest of the liver tissue from radiation.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma in Patients With Portal Vein Thrombosis
Study Start Date : March 2009
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Therasphere Device: TheraSphere
TheraSphere are microspheres with y-90 a radioactive material that will be injected into the liver through a blood vessel.
Other Name: There are no other names for this device.

Primary Outcome Measures :
  1. Response rate to the administration of Therasphere [ Time Frame: Participants will be followed through 1 year after the procedure at 1 month, 3 months, 6 months and 1 year visits ]

Secondary Outcome Measures :
  1. Progression free survival for patients with unresectable liver cancer. [ Time Frame: Participants will be followed through 1 year after receiving treatment ]
    Patients will be followed after treatment at 1 month, 3 months, 6 months, and 1 year.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 yrs of age or older
  • Diagnosis of Hepatocellular Carcinoma
  • Portal Vein Thrombosis
  • ECOG performance < 2

    ->4 weeks since prior radiation, surgery or chemotherapy.

  • Life expectancy > 3 months
  • Able to provide written informed consent process in accordance with institutional review boards guidelines.

Exclusion Criteria:

  • Contraindications to angiography and selective visceral catheterization.
  • Evidence of blood flow to the lung from the liver greater than 16.5 mCi
  • Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow.
  • Significant extrahepatic disease.
  • Severe liver disfunction of pulmonary insufficiency.
  • Active uncontrolled infection.
  • Significant underlying medical or psychiatric illness.
  • Pregnancy. Patients will be excluded if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.

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): NCT01556282

United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Principal Investigator: Hyun s Kim, MD Emory University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hyun Kevin Kim, MD,FSIR Director of Interventional Radiology and Image Guided Medicine, Emory University Identifier: NCT01556282     History of Changes
Other Study ID Numbers: IRB00015167
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014

Keywords provided by Hyun Kevin Kim, Emory University:
Hepatocellular Carcinoma
portal vein thrombosis

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Venous Thrombosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases