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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
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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
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Secondary ID [1]
314544
0
none
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Universal Trial Number (UTN)
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Trial acronym
IMPACT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
breast cancer
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Condition category
Condition code
Cancer
333970
333970
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0
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Breast
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Public Health
334049
334049
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
331171
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Diagnosis / Prognosis
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Intervention code [2]
331220
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Treatment: Devices
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Image quality metrics (composite outcome and includes spatial resolution, signal to noise ratio, contrast to noise measurements)
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Assessment method [1]
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objective (spatial resolution, contrast to noise ratio, signal to noise ratio, etc.) and subjective (visual grading characteristics assessment). The objective measures will be measured using X-TRACT which is a software that calculates various objective image quality measures on image modalities including mammograms and PB-CT scans. Image quality measures will be assessed on the PB-CT scans and reported descriptively. Comparisons will be made within the participant sample (e.g., across different breast densities) and participant mammograms. They will also be compared against previously published data, including phantom and mastectomy studies. For subjective visual grading, image readers (e.g. radiologists) will be given a series of images and asked to assess them in terms of quality and given a list of criteria. For example, for noise, they will need to select one of the five options: 1. Unacceptable image noise, 2. above average image noise, average image noise, less than average image noise, minimal image noise. The scores between the different participant scans will be compared based on size and density and breast region (e.g. close to chest wall, close to nipple area, etc.). Additionally, post-processing algorithms that are used to process the raw data images can be compared using relative visual grading assessments with two or more images side by side and radiologists will need to compare them in terms of quality (e.g. clearly inferior to or clearly superior to, etc.). These subjective scores are standardised and used in many visual grading studies.
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Timepoint [1]
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Participants will have one PB-CT scan. The primary outcomes (image quality metrics) would be assessed post PB-CT scans.
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Secondary outcome [1]
448135
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Dose
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Assessment method [1]
448135
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Dose measurements will be retrieved from the machine itself and compared to standard mammographic radiation doses.
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Timepoint [1]
448135
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Dose will be measured as part of the PB-CT scan and the machine will provide a dose immediately after the scan.
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Secondary outcome [2]
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Patient comfort: motion sickness
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Assessment method [2]
448610
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The Fast Motion Sickness Scale (FMS) is a well-established tool for assessing motion sickness and quantifies symptoms on a scale of 0 to 20 (pre and post)
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Timepoint [2]
448610
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The surveys will be conducted pre and post PB-CT scans
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Secondary outcome [3]
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Patient comfort: mood
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Assessment method [3]
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Mood will be measured using the State-Trait Anxiety Inventory – State (STAI-S) Fast version, a common tool for evaluating temporary stress response (pre and post)
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Timepoint [3]
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The surveys will be conducted pre and post PB-CT scans
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Secondary outcome [4]
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Patient comfort: overall comfort
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Assessment method [4]
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The open-ended discussions will directly ask participants about how they felt about the scan, if they felt prepared, etc. The same format was used when the PB-CT scanner was tested for comfort (without radiation) in a previous study by the same research team. (post only)
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Timepoint [4]
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The surveys will be after the PB-CT scans only
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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)
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Minimum age
50
Years
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Maximum age
70
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
o Has implants or metal clips in their breast (for example, a previous breast biopsy)
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2025
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Actual
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Date of last participant enrolment
Anticipated
31/12/2025
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Synergy
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Sydney
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
321554
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Monash Health Human Research Ethics Committee A
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Ethics committee address [1]
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https://monashhealth.org/research/resources/resource-library/
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
317692
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28/05/2025
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Approval date [1]
317692
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Ethics approval number [1]
317692
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Summary
Brief summary
This study aims to evaluate the diagnostic performance of PB-CT in a real-world clinical setting and compare the scans to the standard of care (mammography). Who is it for? You may be eligible to join this study if you are a woman aged 50 - 70 years old, have had a mammogram in the past 6 months with no detected breast cancer and have no metal clips in your breasts. You will need to be able to go to the ANSTO facility in Clayton Victoria and able to lie face-down for a couple of minutes. Study details All participants who meet the eligibility criteria in this study will undergo Propagation-Based Phase-Contrast CT (PB-CT) (intervention) for breast imaging. After the intervention, image quality metrics of the scan will be assessed and participants will be surveyed regarding the comfort of the scan. It is hoped that this research project will help us understand how acceptable this new test is for patients, provide imaging data sets to teach radiologists how to read PB-CT scans, and allow diagnostic quality assessments to be made. Together, this research will help guide future improvements in breast screening and diagnostic imaging for cancer detection and treatment planning.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Patrick Brennan
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Address
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Susan Wakil Health Building, Western Avenue, Camperdown, Sydney, NSW, 2050
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Country
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Australia
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Phone
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+61 2 9036 7402
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dania Abu Awwad
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Address
141827
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Susan Wakil Health Building, Western Avenue, Camperdown, Sydney, NSW, 2050
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Country
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Australia
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Phone
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+61 2 8627 4747
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Patrick Brennan
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Address
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Susan Wakil Health Building, Western Avenue, Camperdown, Sydney, NSW, 2050
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Country
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Australia
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Phone
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+61 2 9036 7402
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Fax
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Email
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[email protected]
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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.
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