Clinical trial NCT06993246: Contrast-enhanced Mammography in Women With a Personal History of Breast Cancer and Dense Breast Tissue: Benefit?
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Mammography screening
Contrast-Enhanced Mammography
Dense breasts
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
First posted: 2025-05-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study follows a \*\*prospective cohort design\*\*, where eligible participants are recruited and followed over time to evaluate the outcomes of Contrast-Enhanced Mammography (CEM) in comparison to traditional screening methods like ultrasound and MRI. Participants are women aged 50-69 years with dense breast tissue and a personal history of breast cancer. They will undergo CEM as part of their routine screening process. The study aims to assess key outcomes, including cancer detection rates, biopsy results, patient acceptance, and screening wait times. Data will be collected on screening outcomes, including abnormal interpretation rates, positive predictive values, and follow-up results over two years. The study also compares the performance of CEM with historical data from previous screening modalities.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection Rate of Breast Cancer
timeFrame: Three years from the study start date.
Secondary outcomes:
measure: Lesion Characterization
timeFrame: Up to one year.
measure: Patient Experience
timeFrame: Immediate post-procedure.
Other outcomes:
measure: Procedure Safety
timeFrame: Three years from the study start date.
measure: Cost-Effectiveness
timeFrame: Three years from study start.
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Dr. Jean Seely Principal Investigator,, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: