PET Scan as a Screening Tool for Liver Transplant in Patients With Hepatocellular Carcinoma (HCC)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
peter metrakos, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01320852
First received: December 22, 2010
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

This study aims at testing the utility of PET Scan as a screening tool for liver transplantation in patients with Hepatocellular Carcinoma. Patients being worked up for liver transplant for hepatocellular carcinoma will undergo a PET Scan and will be followed until 2 years after transplantation. At that time survival data will be analysed according to PET Scan results to determine if it can be used to predict outcome.


Condition Intervention
Hepatocellular Carcinoma
Other: PET Scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: PET Scan as a Screening Tool for Liver Transplant in Patients With HCC

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: up to death ] [ Designated as safety issue: No ]
    The primary objective of the study is to compare, according to PET scan results, the post-transplantation overall survival of patients meeting Milan criteria to those not meeting Milan criteria


Enrollment: 100
Study Start Date: December 2010
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Milan Criteria
Patients meeting the Milan Criteria
Other: PET Scan
All patients will have a PET scan as part of their pre-transplant assessment
No Milan Criteria
Patients not meeting the Milan Criteria
Other: PET Scan
All patients will have a PET scan as part of their pre-transplant assessment

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patient over 18 years of age
  • Diagnosis of HCC confirmed by histology if available or by two imaging modalities
  • Able to give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Exclusion Criteria:

  • Unable to give consent to the study
  • Unable to undergo a PET Scan
  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: NCT01320852

Locations
Canada, Quebec
McGill Univeristy Health Centre
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Center
Pfizer
  More Information

No publications provided

Responsible Party: peter metrakos, Director Multiorgan Transplant Program-MUHC, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01320852     History of Changes
Other Study ID Numbers: BMD-09-209
Study First Received: December 22, 2010
Last Updated: October 24, 2013
Health Authority: Canada: Health Canada

Keywords provided by McGill University Health Center:
Transplant

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

ClinicalTrials.gov processed this record on October 21, 2014