Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000358943
Ethics application status
Approved
Date submitted
29/03/2011
Date registered
6/04/2011
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
4D Positron Emission Tomography/Computerised Tomography (PET/CT) in Liver Surgical Planning
Scientific title
A pilot study to investigate the impact of contrast enhanced CT and Gated PET in patients with colorectal liver metastases.
Secondary ID [1] 259878 0
nil
Universal Trial Number (UTN)
U1111-1120-3697
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Liver Metastases 265469 0
Condition category
Condition code
Cancer 265623 265623 0 0
Liver
Cancer 265713 265713 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A standard whole body PET/CT scan will be performed first. This involves a patient lying on a scanning table for around 20 mins while breathing normally. The patient will recieve CT and a PET scan from the base of the brain to thighs.
Then at the conclusion of the whole body PET/CT scan the patient will be administered with IV contrast and asked to hold their breath while a high quality CT scan of the liver is acquired taking about 30 seconds. Once the contrast CT scan has concluded the patient will be instructed to breath normally again and a 10 minute gated PET scan of the liver will be acquired.
Intervention code [1] 264299 0
Diagnosis / Prognosis
Comparator / control treatment
In this trial we are measuring the incremental benefit of the additional scan over whole body scanning alone.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262407 0
To determine the number of positive liver metastases on contrast enhanced respiratory gated 4D PET/CT scanning compared to conventional ungated whole body PET/CT without contrast-enhanced CT.
Timepoint [1] 262407 0
At the time of PET/CT scan
Secondary outcome [1] 273718 0
Feasibility of mid-expiration contrast-enhanced CT of the liver and reasons for any failures. Any patients who are unable to perform a expiration breath hold will be deemed a failure and be recorded by the prinicipal investigator. The percentage of failures will be calculated.
Timepoint [1] 273718 0
At the time of PET/CT scan
Secondary outcome [2] 273719 0
Determine the impact of contrast enhanced respiratory gated PET/CT on treatment decision compared to un-gated whole body PET/CT scanning or contrast enhanced CT scanning alone.
The reporting physician will be shown the whole body PET/CT scan and will be asked to report on the extent of liver disease and anticipated managment. The same physician will then be presented with the contrast enhanced 4D-PET scan. They will be asked if there is any additional disease present and if it would change the anticipated management of the patient using the following criteria:

*High impact: Change in Treatment intention (curative to palliative)
*Medium impact: Change in Treatment type (Surgical to non-surgical)
*Low impact: Plan confirmed
*No impact: Additional scan ignored
Timepoint [2] 273719 0
At the time of PET/CT scan
Secondary outcome [3] 273720 0
To investigate the difference in functional quantification of liver metastases on a contrast enhanced 4D PET scan compared to the un-gated PET scan.
Timepoint [3] 273720 0
At the time of PET/CT scan

Eligibility
Key inclusion criteria
Either histologically or clinically proven colorectal cancer with liver metastases for resection.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Lack of patient compliance for additional scan time requirement
2. Breathing trace technically unsatisfactory for respiratory gating.
3. Allergy to CT radiographic contrast

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients with colorectal cancer referred to the Peter MacCallum PET centre to assess potentially resectable liver metastasis will be approached to participate in the trial. Consent will be sought from patients who fulfil eligibility requirements before they are administered with FDG.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12445 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [2] 12446 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [3] 12447 0
Peter MacCallum Cancer Institute - East Melbourne

Funding & Sponsors
Funding source category [1] 264758 0
Self funded/Unfunded
Name [1] 264758 0
Country [1] 264758 0
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
St Andrews place
East Melbourne, Victoria
3002
Country
Australia
Secondary sponsor category [1] 263878 0
None
Name [1] 263878 0
Address [1] 263878 0
Country [1] 263878 0
Other collaborator category [1] 251904 0
University
Name [1] 251904 0
Monash University
Address [1] 251904 0
School of Biomedical Science
Faculty of Medicine, Nursing and Health Sciences
Monash University
Building 13C, Room 121
Wellington Rd,
Clayton, Victoria 3800, Australia
Country [1] 251904 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266737 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 266737 0
Ethics committee country [1] 266737 0
Australia
Date submitted for ethics approval [1] 266737 0
30/03/2011
Approval date [1] 266737 0
31/08/2011
Ethics approval number [1] 266737 0
11/49

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32405 0
Mr Jason Callahan
Address 32405 0
Peter MacCallum PET Centre, 12 st Andrew Place, east Melbourne, Vic Aus 3002
Country 32405 0
Australia
Phone 32405 0
+613 96565869
Fax 32405 0
Email 32405 0
jason.callahan@petermac.org
Contact person for public queries
Name 15652 0
Jason Callahan
Address 15652 0
Peter MacCallum PET Centre
St Andrews Place
East Melbourne, Vic
3002
Country 15652 0
Australia
Phone 15652 0
+613 96565869
Fax 15652 0
Email 15652 0
jason.callahan@petermac.org
Contact person for scientific queries
Name 6580 0
Jason Callahan
Address 6580 0
Peter MacCallum PET Centre
St Andrews Place
East Melbourne, Vic
3002
Country 6580 0
Australia
Phone 6580 0
+613 96565869
Fax 6580 0
Email 6580 0
jason.callahan@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial no completed


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.