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


N/A
18 Years
N/A
Open (Enrolling)
Both
Liver Cancer, Portal Vein Thrombosis

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate to the administration of Therasphere

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Hyun s Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University

Authority:

United States: Institutional Review Board

Study ID:

00015167

NCT ID:

NCT01556282

Start Date:

March 2009

Completion Date:

December 2017

Related Keywords:

  • Liver Cancer
  • Portal Vein Thrombosis
  • Hepatocellular Carcinoma
  • portal vein thrombosis
  • HCC
  • Liver Neoplasms
  • Thrombosis
  • Venous Thrombosis
  • Carcinoma, Hepatocellular

Name

Location

Emory University HospitalAtlanta, Georgia  30322