TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556282
• Other study ID #: IRB00015167
• Status: Completed
• Phase: N/A
• First received: February 13, 2012
• Last updated: May 23, 2014
• Start date: March 2009
• Est. completion date: January 2014

Study information

• Verified date: May 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Portal Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Progression free survival for patients with unresectable liver cancer.	Patients will be followed after treatment at 1 month, 3 months, 6 months, and 1 year.	Participants will be followed through 1 year after receiving treatment	No