Does Supplemental Contrast-enhanced Mammography Have a Benefit in Women With a Personal History of Breast Cancer and Dense Breast Tissue? A Prospective Cohort Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Detection Rate of Breast Cancer
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
There are no additional parties masked in this clinical trial. The study is open-label, meaning that participants, care providers, investigators, and outcomes assessors are all aware of the intervention being performed (Contrast-Enhanced Mammography). No masking of roles is applied in this study.
Eligibility Criteria
- Ages
- 50 Years to 69 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
**Contrast-Enhanced Mammography for Supplemental Breast Cancer Screening**
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.
Intervention: Contrast-Enhanced Mammography (CEM) (Diagnostic Test)
Outcomes
Primary Outcomes
Detection Rate of Breast Cancer
Time Frame: 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.)
- Patient Experience(Immediate post-procedure.)
Investigators
Jean Seely
Physician Medical Imaging
Ottawa Hospital Research Institute