Breast Cancer
Conditions
Brief summary
This research study is being done to determine if Contrast Enhanced Digital Mammography (CEDM) can improve breast cancer detection and can be used as an additional screening method to the standard mammographic screening.
Interventions
High-resolution, low-energy, full-field digital mammography (FFDM) image and contrast-enhanced image
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Patients are prospectively assigned to the CEDM /screening intervention which may lead to additional screening or biopsy based on the study schema.
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women aged 35 and had a negative routine mammogram within 6 months. * Qualifies as intermediate or high-risk (\>15% lifetime risk of breast cancer as defined by IBIS version 8).
Exclusion criteria
* Known breast cancer * Previously had negative MBI or MRI within 12 months of study * Pregnant or lactating * Contraindication to intravenous iodinated contrast * Unable to understand or sign informed consent * Self-reported signs or symptoms of breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast Cancer | 3 years | Number of subjects diagnosed with breast cancer |
Countries
United States
Outcome results
None listed