Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000604404
Ethics application status
Approved
Date submitted
16/11/2007
Date registered
23/11/2007
Date last updated
31/10/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A study looking at the effect positron emission tomography (PET) scans have on the treatment decisions specialists make in patients with suspected cancer of the pancreas.
Scientific title
A prospective study investigating the impact of the addition of FDG-PET/CT on treatment decisions compared to standard pre-operative work up for patients with suspected pancreatic, peri-ampullary or bile duct malignancies
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic and peri-ampullary cancers. 2557 0
Condition category
Condition code
Cancer 2659 2659 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adding 18 fluorodeoxyglucose positron emission tomography (FDG-PET) which,in other cancers, is better able to pick up cancer spread than other tests are. This scan will be done once at the time of diagnosis and staging.
Intervention code [1] 2290 0
Diagnosis / Prognosis
Comparator / control treatment
Standard or routine pre-operative investigations. This may include
• Dual phase Computed Tomography (CT)
• USS (ultrasound)
• Endoscopic ultrasound
• MRI (magnetic resonance imaging)
• ERCP (endoscopic retrograde cholangiopancreatography) with or without stenting
• MRCP (magnetic resonance cholangiopancreatogrophy
• Percutaneous biliary drainage/ stenting
• Laparoscopy [ ideally, (but not necessarily) this will take place just prior to surgery and after all other pre-operative investigations including PET/CT, have been performed ]
Control group
Active

Outcomes
Primary outcome [1] 3569 0
Define the percentage of patients in whom, as a result of FDG PET/CT, there is an appropriate change of management plan, treatment strategy or staging.
Timepoint [1] 3569 0
At the time of staging, at operation or during follow up which is scheduled to occur at 1,3,6,9,12,18,24,30 and 36 months post surgery
Secondary outcome [1] 5974 0
To compare the staging accuracy of standard imaging alone with the staging accuracy of the combination of standard imaging and PET/CT scanning
Timepoint [1] 5974 0
At the time of staging, at operation or during follow up which is scheduled to occur at 1,3,6,9,12,18,24,30 and 36 months post surgery
Secondary outcome [2] 6009 0
Define the percentage of patients in whom, as a result of FDG PET/CT, there is an inappropriate change of management plan, treatment strategy or staging
Timepoint [2] 6009 0
At the time of staging, at operation or during follow up which is scheduled to occur at 1,3,6,9,12,18,24,30 and 36 months post surgery

Eligibility
Key inclusion criteria
•Suspected or proven localized pancreatic, ampullary or bile duct malignancy on the basis of standard investigations;
•= 18 years old;
•Deemed suitable, based on tumour stage and medical fitness, to potentially undergo surgery or radiotherapy with curative intent;
•Available for follow up for at least 12 months from the date of PET/CT scanning;
•Able to provide Informed Consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Claustrophobia;
• Uncontrolled diabetes mellitus;
• Pregnancy;
• Unable to provide informed consent;
• Inability to undergo PET/CT study;
• Any disease, condition, physical examination finding or clinical laboratory finding which, in the opinion of the investigator, makes the patient inappropriate for the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 327 0
4032

Funding & Sponsors
Funding source category [1] 2819 0
Hospital
Name [1] 2819 0
Royal Brisbane Hospital
Country [1] 2819 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane Hospital
Address
Herston Road
Herston QLD 4032
Country
Australia
Secondary sponsor category [1] 2532 0
None
Name [1] 2532 0
Address [1] 2532 0
Country [1] 2532 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4755 0
Royal Brisbane and Womens Hospital
Ethics committee address [1] 4755 0
Herston Road
Herston QLD 4029
Ethics committee country [1] 4755 0
Australia
Date submitted for ethics approval [1] 4755 0
15/10/2007
Approval date [1] 4755 0
Ethics approval number [1] 4755 0

Summary
Brief summary
In addition to the standard pre-operative investigations you will also
undergo a PET scan. Your results will be compared to people who only
receive the routine pre-operative investigations, to see if the use of
the PET scan changes the treatment plan.

A PET scan is a non-invasive nuclear imaging test. In other cancers,
particularly lung cancer, this scan can detect the spread of cancer
better than other tests. If you have a suspected pancreatic cancer, the
usual tests might include a CT (computed tomography) scan, ultrasound,
MRI (magnetic resonance imaging) scan and an ERCP (endoscopic retrograde
cholangiopancreatography). If a PET scan helps show the extent of the
cancer better, your diagnosis will be more accurate and this might spare
you unnecessary major surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28191 0
Address 28191 0
Country 28191 0
Phone 28191 0
Fax 28191 0
Email 28191 0
Contact person for public queries
Name 11348 0
Matthew Burge
Address 11348 0
Royal Brisbane Hospital
Herston Road
Herston QLD 4032
Country 11348 0
Australia
Phone 11348 0
+61 7 36368111
Fax 11348 0
+61 2 32522746
Email 11348 0
[email protected]
Contact person for scientific queries
Name 2276 0
Matthew Burge
Address 2276 0
Royal Brisbane Hospital
Herston Road
Herston QLD 4032
Country 2276 0
Australia
Phone 2276 0
+61 7 36368111
Fax 2276 0
+61 2 32522746
Email 2276 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseHigh SUVmax on routine pre-operative FDG-PET predicts early recurrence in pancreatic and peri-ampullary cancer.2022https://dx.doi.org/10.1016/j.hpb.2022.01.005
N.B. These documents automatically identified may not have been verified by the study sponsor.