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

Jean Seely

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Diagnostic Test: Contrast-Enhanced Mammography (CEM)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06993246

OHSN- REB 20240828-01H

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 50 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

**Contrast-Enhanced Mammography for Supplemental Breast Cancer Screening**

Experimental group

Description:

This arm involves participants undergoing Contrast-Enhanced Mammography (CEM) as a supplemental screening method for breast cancer. CEM combines standard mammography with iodinated contrast medium to improve lesion visualization and tumor detection, particularly in women with dense breast tissue. Participants will receive CEM during a single visit at the Rose Ages Breast Health Centre, and their results will be evaluated for cancer detection, abnormal interpretation rates, and biopsy outcomes.

Treatment:

Diagnostic Test: Contrast-Enhanced Mammography (CEM)