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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
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
Universal Trial Number (UTN)
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
Cancer 265713 265713 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Study type
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

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

Key inclusion criteria
Either histologically or clinically proven colorectal cancer with liver metastases for resection.
Minimum age
18 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
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
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Address [1] 264758 0
Country [1] 264758 0
Primary sponsor type
Peter MacCallum Cancer Centre
St Andrews place
East Melbourne, Victoria
Secondary sponsor category [1] 263878 0
Name [1] 263878 0
Address [1] 263878 0
Country [1] 263878 0
Other collaborator category [1] 251904 0
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

Ethics approval
Ethics application status
Ethics committee name [1] 266737 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 266737 0
St Andrew's Place
East Melbourne, Vic
Ethics committee country [1] 266737 0
Date submitted for ethics approval [1] 266737 0
Approval date [1] 266737 0
Ethics approval number [1] 266737 0

Brief summary
The hypothesis of this study is that an enhanced PET/CT scanning protocol using new technology to monitor patient's breathing will detect disease that was not seen by any other scanning technique. The intervention being tested is the new respiratory scanning technology. This technology is able to create a video of a patient breathing rather that a snap shot to correct any blurring caused by normal breathing.
Trial website
Trial related presentations / publications
Public notes

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
Phone 32405 0
+613 96565869
Fax 32405 0
Email 32405 0
Contact person for public queries
Name 15652 0
Mr Jason Callahan
Address 15652 0
Peter MacCallum PET Centre
St Andrews Place
East Melbourne, Vic
Country 15652 0
Phone 15652 0
+613 96565869
Fax 15652 0
Email 15652 0
Contact person for scientific queries
Name 6580 0
Mr Jason Callahan
Address 6580 0
Peter MacCallum PET Centre
St Andrews Place
East Melbourne, Vic
Country 6580 0
Phone 6580 0
+613 96565869
Fax 6580 0
Email 6580 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
Trial no completed
What supporting documents are/will be available?
No other documents available
Summary results
No Results