ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cancer metastasis

Condition category

Condition code

Cancer

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]

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]

Difference in standardized uptake value (SUV) between standard PET/CT and breath hold PET/CT.

Timepoint [1]

Single timepoint, at diagnostic investigation (PET/CT).

Secondary outcome [1]

Total number of metastatic liver lesions

Timepoint [1]

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]

Difference in metabolic tumour volume between standard PET/CT and breath hold PET/CT for metastatic liver lesions

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

TAS

Recruitment hospital [1]

Royal Hobart Hospital - Hobart

Recruitment postcode(s) [1]

7000 - Hobart

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Hobart Hospital

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Tony Bose

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

University of Tasmania Human Research Ethics Committee

Ethics committee address [1]

http://www.utas.edu.au/research-admin/research-integrity-and-ethics-unit-rieu

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/04/2024

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The purpose of this study is to determine if the addition of a short 20 second breath hold during a positron emission tomography/computed tomography (PET/CT) scan is able to improve the characterization of metastatic liver lesions.

Who is it for?
You may be eligible for this study if you are a patient aged 50 years or over who has been referred for initial staging or staging of cancer any type with suspected or confirmed multiple (2 or more) liver metastases.

Study details
After completing the regular PET/CT that was requested by their referring specialist, participants will be asked to perform a 20-second breath hold whilst CT images are acquired. Following a short break where they are allowed to breathe normally, participants will be asked to perform another 20-second breath hold for PET image acquisition. We will assess the total number of liver lesions, as well as their size and metabolic activity and compare the breath hold images with the standard whole body PET/CT images.

It is hoped that findings from this study will help inform researchers of the utility of breath holds in improving detection of metastases during PET/CT imaging.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Tony Bose

Address

Department of Medical Imaging, Ground Floor H Block, Royal Hobart Hospital, 40 Liverpool St, Hobart, Tasmania, 7000.

Country

Australia

Phone

+61 424343183

Fax

tony.bose@ths.tas.gov.au

Contact person for public queries

Name

Tony Bose

Address

Department of Medical Imaging, Ground Floor H Block, Royal Hobart Hospital, 40 Liverpool St, Hobart, Tasmania, 7000.

Country

Australia

Phone

+61 424343183

Fax

tony.bose@ths.tas.gov.au

Contact person for scientific queries

Name

Tony Bose

Address

Department of Medical Imaging, Ground Floor H Block, Royal Hobart Hospital, 40 Liverpool St, Hobart, Tasmania, 7000.

Country

Australia

Phone

+61 424343183

Fax

tony.bose@ths.tas.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
21962	Study protocol					387559-(Uploaded-02-04-2024-10-02-31)-Study-related document.doc
22043	Informed 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.

Trial Review

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