Contrast-enhanced Mammography in Women With a Personal History of Breast Cancer and Dense Breast Tissue: Benefit?

Primary Outcome Measure: 1. 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.

• Contrast-Enhanced Mammography (CEM) (Diagnostic test): The 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.

Primary outcomes

• Detection Rate of Breast Cancer [Three years from the study start date.]: 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.

Secondary outcomes

• Lesion Characterization [Up to one year.]: 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 [Immediate post-procedure.]: A patient-reported survey measuring comfort, satisfaction, and perceived usefulness of CEM compared to traditional mammography.

Other outcomes

• Procedure Safety [Three years from the study start date.]: Monitor and report any adverse events, including allergic reactions to the contrast medium and other side effects during and after the procedure.
• Cost-Effectiveness [Three years from study start.]: 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.

Sex: Female, ages: 50 Years to 69 Years

Inclusion Criteria:

* 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)
* No evidence of renal disease

Exclusion Criteria:

* Patients with renal insufficiency (reduced eGFR <20ml/min)
* Previous allergic reactions to Iodine-based contrast.
* Prior contrast allergy (CT contrast)
* Thyroid Disease

• Dr. Jean Seely Principal Investigator,, MD FRCPC, Principal investigator, Ottawa Hospital Research Institute