TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis

Not Applicable

Completed

• Conditions: Liver Cancer; Portal Vein Thrombosis
• Interventions: Device: TheraSphere

• Registration Number: NCT01556282
• Lead Sponsor: Emory University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-16
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-23
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therasphere	TheraSphere	-

Primary Outcome Measures

Name	Time	Method
Response rate to the administration of Therasphere	Participants will be followed through 1 year after the procedure at 1 month, 3 months, 6 months and 1 year visits

Secondary Outcome Measures

Name	Time	Method
Progression free survival for patients with unresectable liver cancer.	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.

Trial Locations

Locations (1)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States