Liver Cancer, Portal Vein Thrombosis
Conditions
Keywords
Hepatocellular Carcinoma, portal vein thrombosis, HCC
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.
Interventions
DEVICETheraSphere
TheraSphere are microspheres with y-90 a radioactive material that will be injected into the liver through a blood vessel.
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed