TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2014-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Liver Cancer Portal Vein Thrombosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Therasphere

Group Type EXPERIMENTAL

TheraSphere

Intervention Type DEVICE

TheraSphere are microspheres with y-90 a radioactive material that will be injected into the liver through a blood vessel.

Interventions

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TheraSphere

TheraSphere are microspheres with y-90 a radioactive material that will be injected into the liver through a blood vessel.

Intervention Type DEVICE

Other Intervention Names

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There are no other names for this device.

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No