This study aims to assess the effectiveness of Contrast-Enhanced Mammography (CEM)as an alternative to traditional ultrasound for breast cancer screening in women with dense breasts and a personal history of breast cancer. CEM combines standard mammography with a contrast agent to better detect tumors, particularly in women with dense tissue where traditional mammograms may miss signs of cancer. The study will compare CEM with ultrasound and MRI to determine its accuracy in detecting cancer, reduce wait times for screening, and provide a more affordable option than MRI. Women who participate will have their screening done in one visit, improving convenience and access. The study will track cancer detection rates, biopsy results, and patient satisfaction over two years to evaluate the benefits of CEM for early breast cancer detection.
Women presenting at Rose Ages Breast Health Center, who are currently waiting for supplemental screening Ultrasound, according to pre-established guidelines at TOH for supplemental screening.
Women ages 50-69 years of age
Those willing to participate in the study, sign an informed consent and undergo IV iodinated contrast injection
Women with dense breasts (category C or D) and normal mammograms (BI-RADS 1 or 2)
Patients with renal insufficiency (reduced eGFR <20ml/min)
Previous allergic reactions to Iodine-based contrast.
Prior contrast allergy (CT contrast)
Thyroid Disease
Single group
Contrast-Enhanced Mammography (CEM)
Diagnostic testThe intervention involves the use of contrast-enhanced mammography (CEM) to supplement standard mammography for breast cancer screening. This method utilizes iodinated contrast medium to enhance the visualization of breast lesions by assessing tumor neovascularization. CEM will be offered to women with dense breast tissue who are currently awaiting supplemental ultrasound screening. It is designed to be performed in conjunction with regular mammography, offering a more efficient and cost-effective alternative to MRI, with comparable sensitivity in detecting breast cancer. Participants will undergo the CEM procedure in a single visit, allowing for reduced wait times and improved detection rates compared to traditional methods. The procedure is well-tolerated, with minimal side effects, and provides a quicker and more accessible option for supplemental breast cancer screening.
Detection Rate of Breast Cancer
The primary outcome measure is the detection rate of breast cancer in women with dense breast tissue using contrast-enhanced mammography (CEM). The sensitivity, specificity, and overall accuracy of CEM in detecting malignancies will be compared to conventional mammography and ultrasound.
Lesion Characterization
Assessment of the ability of CEM to accurately characterize breast lesions in terms of malignancy (benign or malignant). This will be evaluated by comparing CEM findings with biopsy results.
Patient Experience
A patient-reported survey measuring comfort, satisfaction, and perceived usefulness of CEM compared to traditional mammography.
Procedure Safety
Monitor and report any adverse events, including allergic reactions to the contrast medium and other side effects during and after the procedure.
Cost-Effectiveness
Evaluation of the cost-effectiveness of CEM compared to conventional breast cancer screening methods, taking into account the costs of imaging, diagnosis, and follow-up procedures.
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Jean Seely
Lead sponsor
Ottawa Hospital Research Institute
Sponsor institution
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
