TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis

Emory University

Status

Completed

Conditions

Portal Vein Thrombosis

Liver Cancer

Treatments

Device: TheraSphere

Study type

Interventional

Funder types

Other

Identifiers

NCT01556282

IRB00015167

Details and patient eligibility

About

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

Full 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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.