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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000790044
Ethics application status
Approved
Date submitted
9/09/2010
Date registered
23/09/2010
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Date results information initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to investigate the impact of Respiratory Gated Positron Emission Tomography (PET) scanning on classification and diagnostic accuracy in patients with Solitary Pulmonary nodules
Scientific title
A pilot study to investigate the impact of Respiratory Gated Positron Emission Tomography (PET) scanning on classification and diagnostic accuracy in patients with Solitary Pulmonary nodules
Secondary ID [1] 252666 0
na
Secondary ID [2] 296644 0
nil known
Universal Trial Number (UTN)
U1111-1116-8784
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solitary Pulmonary Nodules (SPN) 258160 0
Condition category
Condition code
Cancer 258339 258339 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A patient with a SPN will receive a Respiratory Gated (4D) PET scan as well as their whole body PET scan. The participant will have a 20minute whole body Positron Emission Tomography/Computerised Tomography (PET/CT) scan as per normal. Immediatly after the whole body scan the patient will have a 10minute 4D scan. The total scan time is approximatly 30 minutes.

The participant will have to remain still for both scans and try to breath in a regular pattern. The only difference between the two scans is that a breathing trace will be recorded for the 4D scan.
Intervention code [1] 257183 0
Diagnosis / Prognosis
Comparator / control treatment
The result of the whole body scan will be compred to the result from the 4D scan
Control group
Active

Outcomes
Primary outcome [1] 259193 0
To determine the number of patients who have a change in classification as a result of the addition of a 4D PET scan. The reporting doctor will first make a diagnosis based on the whole body scan. Then the doctor will look and the 4D PET scan and any change in diagnosis as a result of the additional information will be recorded.
Timepoint [1] 259193 0
At time of reporting
Secondary outcome [1] 265557 0
To determine any change in diagnostic accuracy of Positron Emission Tomography/ Computerised Tomography (PET/CT) scanning in SPN's as a result of the addition of a 4D PET scan through long term follow up.
Timepoint [1] 265557 0
The diagnosis will be confirmed by either biopsy or observation of the lesion on additional imaging. The method of follow up is determined by the participant's reffering physician. The follow up period will be no longer than 12 months.

Eligibility
Key inclusion criteria
Evidence of a solitary pulmonary nodule with no histopathology for evaluation with Fluorodeoxyglucose (FDG) PET/CT scanning.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Breathing trace technically unsatisfactory for respiratory gating

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)
All requests for PET/CT scans to investigate solitary pulmonary nodules will be assessed for eligibility. During the whole body scan the performing technologist will assess the patient breathing cycle and nodule position for suitability to have a 4D PET scan.
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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 257630 0
Self funded/Unfunded
Name [1] 257630 0
Address [1] 257630 0
Country [1] 257630 0
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
12 St Andrews Place
East Melbourne
Victoria, 3002
Country
Australia
Secondary sponsor category [1] 256851 0
None
Name [1] 256851 0
Address [1] 256851 0
Country [1] 256851 0
Other collaborator category [1] 251494 0
University
Name [1] 251494 0
Monash university
Address [1] 251494 0
Dept of Medical Imaging & Radiation Sciences
School of Biomedical Sciences
Faculty of Medicine, Nursing & Health Sciences Monash University, 3800 Clayton, Victoria
Country [1] 251494 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259646 0
Peter MacCallum Human Research Ethics Committee (HREC)
Ethics committee address [1] 259646 0
12 St Andrews Place
East Melbourne
Victoria, 3002
Ethics committee country [1] 259646 0
Australia
Date submitted for ethics approval [1] 259646 0
07/10/2010
Approval date [1] 259646 0
22/11/2010
Ethics approval number [1] 259646 0

Summary
Brief summary
This is a pilot study to investigate a new scanning technique called respiratory gated (4D) PET scanning in patients with solitary pulmonary nodules.

Who is it for?
You can be part of this trial is you have a single round lesion in your lung that needs investigation with a PET scan.

Trial details
The participants will recieve their whole body PET scan as per normal but they will have an additional 4D PET scan that will take an extra 10 minutes. The 4D PET scan is a scan that will create a movie of the lung breathing. This movie can reduce blurring of lesions caused by movement due to normal breathing.

The study aims to see the proportion of patients who have a change in the way the cancer is classified as a result of the additional 4D PET scan
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31630 0
Mr Jason Callahan
Address 31630 0
Peter MacCallum Centre for Molecular Imaging 12 St Andrews Place East Melbourne Victoria, 3002
Country 31630 0
Australia
Phone 31630 0
+61 (0)416480599
Fax 31630 0
Email 31630 0
jason.callahan@petermac.org
Contact person for public queries
Name 14877 0
Mr Jason Callahan
Address 14877 0
Peter MacCallum Centre for Molecular Imaging
12 St Andrews Place
East Melbourne
Victoria, 3002
Country 14877 0
Australia
Phone 14877 0
+61 (0)416480599
Fax 14877 0
Email 14877 0
jason.callahan@petermac.org
Contact person for scientific queries
Name 5805 0
Mr Jason Callahan
Address 5805 0
Peter MacCallum Centre for Molecular Imaging
12 St Andrews Place
East Melbourne
Victoria, 3002
Country 5805 0
Australia
Phone 5805 0
+61 (0)416480599
Fax 5805 0
Email 5805 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
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary