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

Hepatocellular Carcinoma Clinical Trial

Official title:

PET Scan as a Screening Tool for Liver Transplant in Patients With HCC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320852
• Other study ID #: BMD-09-209
• Status: Completed
• Phase: N/A
• First received: December 22, 2010
• Last updated: October 24, 2013
• Start date: December 2010
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• PET Scan
All patients will have a PET scan as part of their pre-transplant assessment

Locations

Country	Name	City	State
Canada	McGill Univeristy Health Centre	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	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	up to death	No