Breast Screening
Conditions
Keywords
Mammography, Contrast-Enhanced Spectral Mammography, 19-116
Brief summary
The purpose of this study is to test whether contrast-enhanced spectral mammography (CESM) may be able to reduce the number of unnecessary biopsies in women whose screening mammograms had abnormal findings.
Interventions
DIAGNOSTIC_TESTContrast-Enhanced Spectral Mammography
A standard dose of contrast material for other contrast mammography examinations and for body CT scanning, 1.5 ml/kg of Iohexol350 will be injected intravenously (IV) using a power injection (3-4 ml/s) with a maximum does of 150 ml. The IV injection is performed while the patient is in a sitting position. The mammogram will be performed in a standing position.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women called back from a screening mammography by either FFDM or tomosynthesis with soft tissue abnormalities including masses, asymmetries, focal asymmetries or architectural distortion with or without calcifications. Patients will be questioned regarding the possibility of pregnancy and will need a negative pregnancy test prior the study intervention.
Exclusion criteria
* Age \<30 years old * Screening mammography with only calcifications abnormalities * Male patients * Pregnant or lactating patients * Patients with any allergy to iodinated contrast * Patients with eGFR \< 45 * Patients that may be treated with radioactive iodine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of CESM compared to mammography | 2 years | The radiologist will interpret the low energy images and record their findings. |
Countries
United States
Outcome results
None listed