None listed
Conditions
Brief summary
Women recalled from breast cancer screening receive further work-up with conventional imaging and biopsy when required. This study aims to demonstrate the superiority of Contrast Enhanced Mammography (CEM) in reducing benign biopsies when compared with standard assessment (conventional imaging) in women recalled for further assessment from breast cancer screening. All participants that opt to participate will have standard assessment (Digital Breast Tomosynthesis) and a contrast enhanced mammogram (CEM). (CEM) is a mammogram taken after an injection of an iodine x-ray dye (contrast agent) into a vein. CEM provides more information than shown by a conventional mammogram alone as it also demonstrates blood distribution. CEM is often performed simultaneously with tomosynthesis (a 3D mammogram) and has been proven to improve the detection of breast cancer. You may be eligible to participate in this study if you are a woman aged 40 years and over recalled to assessment post-screening at Breast Screen ACT from 13 January 2026 – 31 December 2026. What are the indications and benefits of CEM? There are many benefits to having CEM as part of your BreastScreen work-up imaging. Early detection is the best defence against breast cancer and can dramatically affect survival rates. CEM is reported to increase breast cancer detection, provide better information about the extent of newly diagnosed breast cancers and allows effective evaluation for breast cancer treatment planning. Additionally, CEM can save time and minimise anxiety as the test has the potential to reduce unnecessary breast imaging to a single examination.
Interventions
Contrast Enhanced Mammography (CEM). CEM combines dual-energy mammography with the use of iodinated contrast media to demonstrate lesions with malignant enhancement.
All clients recalled for assessment for an abnormality detected on screening mammography will be eligible to participate.
Cohort 1: Clients assessed with Standard assessment and CEM from 13 January 2026 - 31 December 2026.
All participants must provide written consent prior to entering the research project and undertaking CEM imag
Contrast Enhanced Mammography (CEM). CEM combines dual-energy mammography with the use of iodinated contrast media to demonstrate lesions with malignant enhancement. All clients recalled for assessment for an abnormality detected on screening mammography will be eligible to participate. Cohort 1: Clients assessed with Standard assessment and CEM from 13 January 2026 - 31 December 2026. All participants must provide written consent prior to entering the research project and undertaking CEM imaging. Procedure: • Standard Assessment: Bilateral Digital Breast Tomosynthesis imaging (3D imaging) • CEM: Dual energy contrast enhanced mammogram imaging (HE + LE 2D image) Intervention: • Media: Omnipaque350 • 10mL flush immediately prior • Flow Rate: 3ml/sec • Volume: 1.5ml/kg – minimum 75ml – maximum 100mL • 10mL flush immediately following Radiography staff will administer the iodinated contrast media immediately prior to mammography imaging. Imaging Workflow: • Contrast Administration (approx. 30 seconds injection time) • 2-minute window prior to imaging • 6-minute window for imaging (4 view mammography examination) Administration of iodinated Contrast: Radiographers Adherence: All participants must provide written consent prior to entering the research project and undertaking CEM imaging. Written consent will be kept with the client medical records associated with the BreastScreen Assessment pathway.
Sponsors
Canberra Health Services Major Research Grant
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All clients 40 years and over, attending for a recall to Assessment appointment from 13 January 2026 – 31 December 2026, at BreastScreen ACT will be invited to participate.
Exclusion criteria
Breast implants Known allergies to iodinated contrast agents History of multiple allergies requiring medical treatment Renal failure Presence of risk factors for or a known history of impaired renal function (as identified using the IV contrast administration guidelines). Age over 65 if recent (< 3month) estimated Glomerular Filtration Rate (eGFR) not available Diabetes on metformin Other contraindications to contrast agents (e.g. Myasthesnia gravis, thyroid disease). Poor mobility/physical limitations that would make CEM impractical to perform. Unable to provide informed written consent.
Outcome results
None listed