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

NCT ID: NCT01320852

Last Updated: 2013-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Keywords

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Transplant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Milan Criteria

Patients meeting the Milan Criteria

Group Type ACTIVE_COMPARATOR

PET Scan

Intervention Type OTHER

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

No Milan Criteria

Patients not meeting the Milan Criteria

Group Type OTHER

PET Scan

Intervention Type OTHER

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

Interventions

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PET Scan

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Responsible Party

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peter metrakos

Director Multiorgan Transplant Program-MUHC

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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McGill Univeristy Health Centre

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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BMD-09-209

Identifier Type: -

Identifier Source: org_study_id