PET Scan as a Screening Tool for Liver Transplant in Pati... | NCT01320852

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

NCT01320852

Sponsor

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

Status

Completed

Last Update Posted

Oct 25, 2013Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma

Interventions

PET Scan

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Sep 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Dec 22, 2010

First Submission Date that Met QC Criteria

Mar 22, 2011

First Posted Date

Mar 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2013

Last Update Posted Date

Oct 25, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

peter metrakos, Director Multiorgan Transplant Program-MUHC, McGill University Health Centre/Research Institute of the McGill University Health CentrePrincipal Investigator

Lead Sponsor

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

Collaborators

Name	Class
Pfizer	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PET Scan	Other	All patients will have a PET scan as part of their pre-transplant assessment	Milan Criteria No Milan Criteria

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McGill Univeristy Health Centre		Montreal	Quebec	H3A 1A1	Canada

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided