TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyun Kevin Kim, Emory University
ClinicalTrials.gov Identifier:
NCT01556282
First received: February 13, 2012
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Liver Cancer
Portal Vein Thrombosis
Device: TheraSphere

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma in Patients With Portal Vein Thrombosis

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Response rate to the administration of Therasphere [ Time Frame: Participants will be followed through 1 year after the procedure at 1 month, 3 months, 6 months and 1 year visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival for patients with unresectable liver cancer. [ Time Frame: Participants will be followed through 1 year after receiving treatment ] [ Designated as safety issue: No ]
    Patients will be followed after treatment at 1 month, 3 months, 6 months, and 1 year.


Enrollment: 35
Study Start Date: March 2009
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therasphere Device: TheraSphere
TheraSphere are microspheres with y-90 a radioactive material that will be injected into the liver through a blood vessel.
Other Name: There are no other names for this device.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556282

Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Hyun s Kim, MD Emory University
  More Information

No publications provided

Responsible Party: Hyun Kevin Kim, MD,FSIR Director of Interventional Radiology and Image Guided Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01556282     History of Changes
Other Study ID Numbers: IRB00015167
Study First Received: February 13, 2012
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Hepatocellular Carcinoma
portal vein thrombosis
HCC

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Thrombosis
Venous Thrombosis
Adenocarcinoma
Carcinoma
Cardiovascular Diseases
Digestive System Diseases
Digestive System Neoplasms
Embolism and Thrombosis
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014