Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001274369p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
13/08/2026
Date registered
Help: Date registered
23/10/2026
Date last updated
Help: Date last updated
23/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
23/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility, acceptability and cost-effectiveness of supplemental imaging with Contrast Breast Imaging (CBI) in BreastScreen clients (MyScreen)
Scientific title
A randomised controlled trial of higher risk BreastScreen clients undergoing supplemental screening with Contrast Breast Imaging (CBI) to determine its feasibility, acceptability and cost-effectiveness (MyScreen)
Additional trial identifiers [1] 318177 0
Nil
Universal Trial Number (UTN)
Trial acronym
MyScreen
Related trial records

Health condition
Health condition(s) studied:
Breast Cancer 343233 0
Condition category
Condition code
Cancer 339339 339339 0 0
Breast
Public Health 339461 339461 0 0
Health promotion/education
Public Health 339462 339462 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Supplemental screening and any additional imaging or biopsies required will be provided at Royal Melbourne Hospital or associated Parkville hospitals by qualified radiographers, with no fees charged to trial participants.

People who consent to the intervention arm will be invited to have supplemental contrast-based imaging organized by the MyScreen trial team.

The additional screening test will be either an MRI or CEM at a hospital associated with The Royal Melbourne Hospital (imaging may be done at RMH, or another Parkville hospital depending on capacity) within 3 months of consent.

Eligible clients aged 50-55 with Category D breast density or aged 40-49 (irrespective of breast density or family history) will be allocated to supplemental screening using MRI.

* An MRI (magnetic resonance imaging) is an imaging technique that uses a large magnet and radio waves combined with an intravenous contrast (a dye injected via needle into a vein) which contains gadolinium to highlight areas of increased blood flow. It does not use radiation. The MRI will take about 30 minutes.

OR

The remainder of eligible clients (aged 50-70 with Category C breast density and potentially high risk due to family history or aged 55-70 with Category D breast density) will be allocated to supplemental screening using CEM.

* A CEM (contrast-enhanced mammography) is an imaging technique that uses a 3D digital mammogram combined with an intravenous injection of iodine-based contrast (a dye injected via needle into a vein). The CEM will take about 30-60 minutes.

Participants will receive the results within about 2 weeks. Findings will be determined through radiology consensus meetings; all biopsies and select cases will be presented at multidisciplinary review meetings of the Parkville breast service. Depending on the findings:

* If there are no additional findings, participants will be contacted with their results. They will continue to be invited for future imaging by BreastScreen Victoria as usual. For those receiving CEM, if they were screened annually before joining MyScreen, their screening date after completing the study will be adjusted to a year after their additional screening tests have been completed.

* If there is a finding of concern, participants will be contacted to discuss the results and make further plans. In some cases, they may be asked to come back for a biopsy, with the results available in 1-2 weeks.

* If participants have findings that require treatment, they will be referred for treatment in the same way as would be done if findings were detected by BreastScreen Victoria.

Participants will also complete two questionnaires (online or on paper) at T1 (within 2 weeks of consent) and T2 (either 3 months following consent or 2 weeks after having been advised of their final supplemental screening results, whichever is latest). Reminders will be given if needed.

Consented participants will also be invited to consent to a potential interview. 50 interviews will be conducted.

Consented participants will also be invited to consent to prospective collection of their Medicare claims records.

Intervention arm participants will be considered ‘active participants’ up to completion of their T2 questionnaire (or if this is not completed, the requisite time to allow completion of that questionnaire), except for participants invited to interviews, for whom active participation will extend to completion of their interview (or if this is not completed, the requisite time to attempt completion of the interview).

Intervention arm participants who cease being active participants will continue to have their data collected for the trial, through data provision from BSV to the trial databases.

BSV clients who are invited to participate but decline will also be invited to complete a short questionnaire exploring barriers to participation (with verbal consent recorded).

Data collected as part of the intervention arm will include digital images of supplemental screens, imaging and biopsy results, participant questionnaire data, participant interview transcripts and data reports from BreastScreen Victoria.

This study will not require any home visits.
Intervention code [1] 335070 0
Early detection / Screening
Description of the comparator or control
The comparator arm comprises eligible higher-risk BSV clients not invited to the intervention arm. They will receive usual screening and appointments at BSV.

MyScreen will collect aggregate data for the comparator arm from BSV, for the purpose of comparing outcomes (prospective screening behaviour and cancer diagnoses) between the intervention and comparator arm.

These data will be shared by BSV in a de-identified format under their existing privacy policy terms of data collection and use, with suitable ethics approval and with approval and oversight from the BSV Research Committee.
Control group
Active

Outcomes
Primary outcome [1] 346545 0
Feasibility of implementing CBI for higher-risk women in the BSA program (recruitment)
Timepoint [1] 346545 0
Assessed at the conclusion of the recruitment period.
Primary outcome [2] 346546 0
Feasibility of implementing CBI for higher-risk women in the BSA program (capacity utilisation)
Timepoint [2] 346546 0
Assessed at the conclusion of the recruitment period.
Primary outcome [3] 346547 0
Acceptability of supplemental screening (consenting to participate in supplemental screening)
Timepoint [3] 346547 0
Assessed at the conclusion of the recruitment period.
Secondary outcome [1] 466338 0
Acceptability of supplemental screening (completing supplemental screening).
Timepoint [1] 466338 0
Assessed at the conclusion of the recruitment period.
Secondary outcome [2] 466339 0
Acceptability of supplemental screening (completion of PROMs questionnaires).
Timepoint [2] 466339 0
Assessed at timepoint T2 (either 3 months after consent or 2 weeks after having been advised of their final test results, whichever is later).
Secondary outcome [3] 469267 0
Acceptability of supplemental screening (invitation uptake by completing consent).
Timepoint [3] 469267 0
Assessed at the conclusion of the recruitment period.
Secondary outcome [4] 469271 0
Acceptability of supplemental screening (attending imaging appointment).
Timepoint [4] 469271 0
Assessed at the conclusion of the recruitment period.

Eligibility
Key inclusion criteria
The study population for the intervention and comparator arms will be:
• NorthWest BreastScreen clients
• aged 40-70 years
• clear most recent routine mammographic screening episode (‘reference screen’) during the intervention arm recruitment period (noting that this excludes screening episodes recalled to assessment with a benign final outcome)
AND
• assessed as being at higher-risk of breast cancer based on either
- having ‘potentially high risk’ of breast cancer due to their family history (as recorded by BSV) and Volpara Category C mammographic breast density, or
- Volpara Category D mammographic breast density (irrespective of family history)
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Exclusion criteria for the intervention arm are as follows:
• Presence of a breast symptom
• Inability to provide informed consent
• Unwillingness to undergo supplemental imaging
• Contraindication to supplemental imaging
- Severe renal failure (eGFR <30)
- Severe allergy to contrast agents
- Contraindications to MRI imaging for those allocated to MRI
• Known high risk gene mutations
• Pregnant or breastfeeding
• Comorbidities that would affect participation.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To select eligible women to be invited to participate, reports of eligible BreastScreen clients will be generated at NWBS, separately for clients eligible for MRI or CEM. These reports will be generated on a regular basis (around every 4-6 weeks).
Each report will include a random number and the list of eligible BreastScreen clients will be sorted by that number. Clients will then be selected for invitation in order from the top of that list. This will ensure that clients invited to the study are selected randomly from eligible clients.
Each newly run report will exclude clients who were previously invited to the trial.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2026
Actual
Date of last participant enrolment
Anticipated
1/05/2028
Actual
Date of last data collection
Anticipated
1/11/2028
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322742 0
University
Name [1] 322742 0
University of Sydney
Country [1] 322742 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 325666 0
None
Name [1] 325666 0
Nil
Address [1] 325666 0
Country [1] 325666 0
Other collaborator category [1] 284057 0
Other Collaborative groups
Name [1] 284057 0
Breast Cancer Trials
Address [1] 284057 0
Country [1] 284057 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 321184 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 321184 0
Ethics committee country [1] 321184 0
Australia
Date submitted for ethics approval [1] 321184 0
01/10/2026
Approval date [1] 321184 0
Ethics approval number [1] 321184 0

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

Contacts
Principal investigator
Name 152934 0
A/Prof Carolyn Nickson
Address 152934 0
Cancer Elimination Collaboration (CEC), University of Sydney, 1 King St, Newtown NSW 2042
Country 152934 0
Australia
Phone 152934 0
+61 4 1127 0728
Fax 152934 0
Email 152934 0
[email protected]
Contact person for public queries
Name 152935 0
Carolyn Nickson
Address 152935 0
CEC, University of Sydney, 1 King St, Newtown NSW 2042
Country 152935 0
Australia
Phone 152935 0
+61 4 1127 0728
Fax 152935 0
Email 152935 0
[email protected]
Contact person for scientific queries
Name 152936 0
Prof Bruce Mann
Address 152936 0
Royal Melbourne Hospital (RMH), Grattan St, Parkville, VIC 3052
Country 152936 0
Australia
Phone 152936 0
+61 3 93476301
Fax 152936 0
Email 152936 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.