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

NCT01320852 | Completed

• 1 other identifier: BMD-09-209
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Keywords

Transplant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Milan Criteria

ACTIVE COMPARATOR

Patients meeting the Milan Criteria

Other: PET Scan

No Milan Criteria

OTHER

Patients not meeting the Milan Criteria

Other: PET Scan

Interventions

PET Scan OTHER

All patients will have a PET scan as part of their pre-transplant assessment

Milan Criteria; No Milan Criteria

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Pfizer: collaborator

Study Sites (1)

McGill Univeristy Health Centre

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Multiorgan Transplant Program-MUHC

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: March 23, 2011
• Study Start: December 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 25, 2013

Record last verified: 2013-10

Locations

CA (1)