Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000422527p
Ethics application status
Not yet submitted
Date submitted
24/03/2024
Date registered
8/04/2024
Date last updated
8/04/2024
Date data sharing statement initially provided
8/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a breath hold PET/CT improve the detection and assessment of metastatic liver lesions?
Scientific title
In adults referred for positron emission tomography/computed tomography (PET/CT) does the addition of a 20 second breath hold PET/CT improve the characterization of suspected liver metastases: a prospective pilot study
Secondary ID [1] 311810 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer metastasis 333332 0
Condition category
Condition code
Cancer 330020 330020 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will undergo the intervention at the end of their standard whole-body PET/CT, thus no additional F18-FDG is required. The intervention in no way affects the diagnostic accuracy of the control and vice versa.
The participant will be instructed by the nuclear medicine technician to perform several deep breaths, then a single deep inspiration following a short countdown from 5 seconds. A low dose non contrast CT of the upper abdomen will be performed (50mAs tube voltage, 120kV tube current, 3mm slice thickness, 2mm increments, diaphragm to inferior liver margin approximately 25cm). Once this breath hold CT is complete, the participant will be asked to regain their breath. After 30 seconds, they will be instructed by the nuclear medicine technician to perform several deep breaths, then a single deep inspiration following a short countdown from 5 seconds. Once at full inspiration by visual confirmation, PET data is acquired in a single bed position of the upper abdomen. After 20 seconds as timed using a digital stopwatch by the nuclear medicine technician, the patient will be instructed to breathe normally. If the breath is interrupted during the PET acquisition, a repeat attempt will be performed. If failed a second time, breath hold will be abandoned.

Adherence to the intervention is controlled by the study investigators, nuclear medicine technicians and supervising radiologist/nuclear medicine physician. Interrupted breath hold for CT is not repeated, in order to ensure minimal radiation to the patient. Interrupted breath hold for PET will be repeated once only, after this the intervention will be abandoned.
Patients are reviewed by a nurse following their standard PET/CT to ensure participant wellness and normal vital observations, which will occur in this study. This is standard care following a PET/CT. No specific additional post-trial provisions are planned.
Intervention code [1] 328260 0
Diagnosis / Prognosis
Comparator / control treatment
Each participant undergoes a standard whole body PET/CT as referred by their treating specialist. The data from this serves as the control. All participants undergo the intervention (20 second breath hold PET/CT), and thus each patient serves as their own control.
Control group
Active

Outcomes
Primary outcome [1] 337777 0
Difference in standardized uptake value (SUV) between standard PET/CT and breath hold PET/CT.
Timepoint [1] 337777 0
Single timepoint, at diagnostic investigation (PET/CT).
Secondary outcome [1] 433286 0
Total number of metastatic liver lesions
Timepoint [1] 433286 0
This will be performed at a single timepoint, at the time (or 1-2 days) following the diagnostic investigation, this will be recorded in the case report form.
Secondary outcome [2] 433287 0
Difference in metabolic tumour volume between standard PET/CT and breath hold PET/CT for metastatic liver lesions
Timepoint [2] 433287 0
Single timepoint, at the time of (or 1-2 days following) the diagnostic intervention (PET/CT), and will be documented in the case report form.

Eligibility
Key inclusion criteria
Age 50 years and over.
Referred for initial staging or restaging of cancer any type with suspected or confirmed multiple liver metastases (two or more).
Able to breath hold for at least 20 seconds
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or breastfeeding
Recent imaging (CT or MR) within 90 days reporting a reduction in metastatic liver tumour size and/or number.

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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Current literature suggests the primary outcome (SUV max) for colorectal liver metastases 4.5.
Using this, estimating a 25% increase in the SUV max in breath holding, power 80% and alpha 0.05, sample size of 26.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
Date of last participant enrolment
Anticipated
1/11/2024
Actual
Date of last data collection
Anticipated
1/11/2024
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 26320 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 42294 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 316147 0
Hospital
Name [1] 316147 0
Royal Hobart Hospital
Country [1] 316147 0
Australia
Primary sponsor type
Individual
Name
Tony Bose
Address
Country
Australia
Secondary sponsor category [1] 318327 0
None
Name [1] 318327 0
None
Address [1] 318327 0
Country [1] 318327 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314974 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 314974 0
Ethics committee country [1] 314974 0
Australia
Date submitted for ethics approval [1] 314974 0
12/04/2024
Approval date [1] 314974 0
Ethics approval number [1] 314974 0

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

Contacts
Principal investigator
Name 133294 0
Dr Tony Bose
Address 133294 0
Department of Medical Imaging, Ground Floor H Block, Royal Hobart Hospital, 40 Liverpool St, Hobart, Tasmania, 7000.
Country 133294 0
Australia
Phone 133294 0
+61 424343183
Fax 133294 0
Email 133294 0
[email protected]
Contact person for public queries
Name 133295 0
Tony Bose
Address 133295 0
Department of Medical Imaging, Ground Floor H Block, Royal Hobart Hospital, 40 Liverpool St, Hobart, Tasmania, 7000.
Country 133295 0
Australia
Phone 133295 0
+61 424343183
Fax 133295 0
Email 133295 0
[email protected]
Contact person for scientific queries
Name 133296 0
Tony Bose
Address 133296 0
Department of Medical Imaging, Ground Floor H Block, Royal Hobart Hospital, 40 Liverpool St, Hobart, Tasmania, 7000.
Country 133296 0
Australia
Phone 133296 0
+61 424343183
Fax 133296 0
Email 133296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To maximize data security this data is not planned to be available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21962Study protocol    387559-(Uploaded-02-04-2024-10-02-31)-Study-related document.doc
22043Informed consent form    387559-(Uploaded-02-04-2024-10-02-31)-Study-related document.docx



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.