TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis

May 23, 2014 updated by: Hyun Kevin Kim, Emory University

A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma in Patients With Portal Vein Thrombosis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • There are no other names for this device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Participants will be followed through 1 year after the procedure at 1 month, 3 months, 6 months and 1 year visits

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants will be followed through 1 year after receiving treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Hyun s Kim, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 13, 2012

First Submitted That Met QC Criteria

March 14, 2012

First Posted (Estimate)

March 16, 2012

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 23, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00015167

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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