Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000636459p
Ethics application status
Submitted, not yet approved
Date submitted
28/05/2025
Date registered
17/06/2025
Date last updated
17/06/2025
Date data sharing statement initially provided
17/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
IMPACT (IMplementation of x-ray PhAse-Contrast Tomography) Clinical Trial: Low dose Propagation-Based Phase-Contrast CT (PB-CT) for Breast Imaging in women 50-70 years old
Scientific title
IMPACT (IMplementation of x-ray PhAse-Contrast Tomography) Clinical Trial: Low dose Propagation-Based Phase-Contrast CT (PB-CT) for Breast Imaging in women 50-70 years old
Secondary ID [1] 314544 0
none
Universal Trial Number (UTN)
Trial acronym
IMPACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 337644 0
Condition category
Condition code
Cancer 333970 333970 0 0
Breast
Public Health 334049 334049 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be a pilot study using Propagation-Based Phase-Contrast CT (PB-CT) (intervention) for breast imaging for the first time. This will be compared to the current standard of care which is mammography. This is because the current stage of the project is serving as a proof of concept and not as a diagnostic tool but the study will be eventually expanded once the initial results of the pilot study are analysed, and subsequently help inform how PB-CT contributes towards breast cancer screening, diagnosis, and treatment planning.

Propagation-based CT (PB-CT) is an advanced type of imaging that creates incredibly detailed 3D pictures of the body. It uses X-rays, just like regular mammograms or CT scans, but it also captures the visibility of fine details, especially soft tissues or subtle changes that might not be seen on a standard CT scan. Standard imaging, such as mammograms and CT, relies on the absorption of x-rays through the body. However, PB-CT uses refraction as well as absorption of x-rays in tissue, and shows particular promise in breast imaging due to its superior sensitivity to soft-tissue tumours. This enables better-quality images to be obtained at lower radiation doses compared to conventional absorption-based CT imaging.

The PB-CT scan takes 12-15 seconds for each breast, and the total set-up is expected to take less than 5 minutes. Participants will be asked to complete some surveys before and after the PB-CT scan, have the procedure explained to them before starting, and ask any questions so the total time spent at ANSTO may be 30 minutes.

A research nurse and radiographer will go over consent with the participant. A radiographer will position and scan the participant with scientists and physicists in the console room. Radiologists will review the images after the scans are complete and processed.

Prior to attending, participants will be screened by the research nurse to ensure they meet the inclusion criteria, including are they able to lie prone for a couple of minutes (to fulfil the scan), and if they have had a mammogram in the past 6 months. Access to their mammogram will be needed prior to attending for the PB-CT scan, and it will be used to compare to the PB-CT scan.
Intervention code [1] 331171 0
Diagnosis / Prognosis
Intervention code [2] 331220 0
Treatment: Devices
Comparator / control treatment
Mammography is used as the control modality, consistent with current standard-of-care imaging and national screening practices. Its inclusion allows for a direct comparative assessment of image quality, diagnostic accuracy (e.g., lesion detectability), and patient-reported outcomes. Comparing PB-CT with mammography ensures relevance to clinical decision-making and positions the technology within an existing diagnostic pathway. This mammogram will not be additional - only participants who have already had a mammogram in the past 6 months with results confirming that there were no abnormalities detected will be included in the study - this will be checked during the screening phase. The mammogram will not be part of the study procedure but rather it would have already been completed prior.
Control group
Active

Outcomes
Primary outcome [1] 341627 0
Image quality metrics (composite outcome and includes spatial resolution, signal to noise ratio, contrast to noise measurements)
Timepoint [1] 341627 0
Participants will have one PB-CT scan. The primary outcomes (image quality metrics) would be assessed post PB-CT scans.
Secondary outcome [1] 448135 0
Dose
Timepoint [1] 448135 0
Dose will be measured as part of the PB-CT scan and the machine will provide a dose immediately after the scan.
Secondary outcome [2] 448610 0
Patient comfort: motion sickness
Timepoint [2] 448610 0
The surveys will be conducted pre and post PB-CT scans
Secondary outcome [3] 448611 0
Patient comfort: mood
Timepoint [3] 448611 0
The surveys will be conducted pre and post PB-CT scans
Secondary outcome [4] 448612 0
Patient comfort: overall comfort
Timepoint [4] 448612 0
The surveys will be after the PB-CT scans only

Eligibility
Key inclusion criteria
o Women aged between 50-70 years old
o Have had a mammogram in the past 6 months with no detected breast cancer
o Able to go to the ANSTO facility in Clayton, Victoria
o Able to lie prone (face-down)
Minimum age
50 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
o Has implants or metal clips in their breast (for example, a previous breast biopsy)

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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319092 0
Government body
Name [1] 319092 0
Synergy
Country [1] 319092 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 321554 0
None
Name [1] 321554 0
Address [1] 321554 0
Country [1] 321554 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317692 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 317692 0
Ethics committee country [1] 317692 0
Australia
Date submitted for ethics approval [1] 317692 0
28/05/2025
Approval date [1] 317692 0
Ethics approval number [1] 317692 0

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

Contacts
Principal investigator
Name 141826 0
Prof Patrick Brennan
Address 141826 0
Susan Wakil Health Building, Western Avenue, Camperdown, Sydney, NSW, 2050
Country 141826 0
Australia
Phone 141826 0
+61 2 9036 7402
Fax 141826 0
Email 141826 0
[email protected]
Contact person for public queries
Name 141827 0
Dania Abu Awwad
Address 141827 0
Susan Wakil Health Building, Western Avenue, Camperdown, Sydney, NSW, 2050
Country 141827 0
Australia
Phone 141827 0
+61 2 8627 4747
Fax 141827 0
Email 141827 0
[email protected]
Contact person for scientific queries
Name 141828 0
Patrick Brennan
Address 141828 0
Susan Wakil Health Building, Western Avenue, Camperdown, Sydney, NSW, 2050
Country 141828 0
Australia
Phone 141828 0
+61 2 9036 7402
Fax 141828 0
Email 141828 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.