Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000747022
Ethics application status
Approved
Date submitted
25/08/2010
Date registered
7/09/2010
Date last updated
26/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving the diagnosis of liver cancer with Positron Emission Tomography (PET) scanners by applying mathematical models and using breathing motion correction methods
Scientific title
Use of kinetic analysis and respiratory gating of Positron Emission Tomography (PET) scans to increase the sensitivity for detection of liver metastases in colon cancer prior to attempted curative surgery.
Secondary ID [1] 252570 0
Nil
Universal Trial Number (UTN)
U1111-1116-7009
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colon cancer 258054 0
Condition category
Condition code
Cancer 258214 258214 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PET scanning, kinetic analysis, respiratory motion correction. This involves 60 additional minutes of PET scanning (after the routine PET tracer injection up until the usual time of commencement of the routine PET scan at 60 minutes post injection). The information for kinetic analysis and respiratory motion correction are obtained during this 60 minute scan.
Intervention code [1] 257086 0
Diagnosis / Prognosis
Comparator / control treatment
Standard images obtained from a routine clinical PET scan
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259078 0
Number of F18-Flourodexoyglucose (FDG) avid cancer secondaries detected in the liver with the modified method compared with standard FDG PET imaging.
Timepoint [1] 259078 0
Baseline only
Secondary outcome [1] 265363 0
Nil
Timepoint [1] 265363 0
Nil

Eligibility
Key inclusion criteria
Previous colon cancer, known or suspected colon cancer metastases in the liver, referred for routine PET scan as part of their clinical workup, able to lie in PET scanner for additional 60 minutes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to undergo PET scanning

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)
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2011
Actual
1/01/2011
Date of last participant enrolment
Anticipated
Actual
1/06/2014
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
10
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 257536 0
Hospital
Name [1] 257536 0
Royal Brisbane and Women's Hospital
Country [1] 257536 0
Australia
Primary sponsor type
Individual
Name
Paul Thomas
Address
Royal Brisbane and Women's Hospital
Butterfield Street
Herston 4029
Queensland
Country
Australia
Secondary sponsor category [1] 256762 0
Hospital
Name [1] 256762 0
Royal Brisbane and Women's Hospital
Address [1] 256762 0
Butterfield Street
Herston 4029
Queensland
Country [1] 256762 0
Australia
Other collaborator category [1] 251456 0
Individual
Name [1] 251456 0
Dr Jye Smith
Address [1] 251456 0
Royal Brisbane and Women's Hospital
Butterfield Street
Herston 4029
Queensland
Country [1] 251456 0
Australia
Other collaborator category [2] 251457 0
Individual
Name [2] 251457 0
Dr David Macfarlane
Address [2] 251457 0
Royal Brisbane and Women's Hospital
Butterfield Street
Herston 4029
Queensland
Country [2] 251457 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259565 0
Royal Brisbane and Women's Hospital Institutional Review Board
Ethics committee address [1] 259565 0
Royal Brisbane and Women's Hospital
Butterfield Street
Herston 4029
Queensland
Ethics committee country [1] 259565 0
Date submitted for ethics approval [1] 259565 0
Approval date [1] 259565 0
21/09/2009
Ethics approval number [1] 259565 0

Summary
Brief summary
This study is aimed at improved PET scanning diagnosis of liver secondaries from colon cancer. There will be no recruitment of patients from outside of the Royal Brisbane and Women's Hospital.
Trial website
Trial related presentations / publications
Optimising the detection of colorectal cancer liver metastases with dynamic FDG PET acquisitions Paul Thomas, Nicholas Dowson, Charles Baker, Jye Smith, Stephen Rose. Poster presentation. Australian and New Zealand Society of Nuclear Medicine Annual Scientific Meeting, Brisbane, 2015
Public notes

Contacts
Principal investigator
Name 31570 0
A/Prof Paul Thomas
Address 31570 0
Specialised PET Services Queensland
Metro North Hospital and Health Service
Royal Brisbane & Women's Hospital
Level 3, Ned Hanlon Building, Butterfield Street,
Herston Qld 4029, Australia
Country 31570 0
Australia
Phone 31570 0
+61736465035
Fax 31570 0
Email 31570 0
[email protected]
Contact person for public queries
Name 14817 0
A/Prof Paul Thomas
Address 14817 0
Royal Brisbane and Women's Hospital
Butterfield Street
Herston 4029
Queensland
Country 14817 0
Australia
Phone 14817 0
+ 61 7 3636 7593
Fax 14817 0
Email 14817 0
[email protected]
Contact person for scientific queries
Name 5745 0
A/Prof Paul Thomas
Address 5745 0
Royal Brisbane and Women's Hospital
Department of Nuclear Medicine
Butterfield Street
Herston 4029
Queensland
Country 5745 0
Australia
Phone 5745 0
+ 61 7 3636 7593
Fax 5745 0
Email 5745 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
No additional documents have been identified.