Contrast-Enhanced Mammography for the Improvement of Surveillance in Women with a Personal History of Breast Cancer
- Asymptomatic women, ages 30-85, with a personal history of breast cancer who have had at least one routine mammogram since treatment
- Women with a history of prior iodinated contrast reaction
- Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions)
- Women who have had bilateral mastectomy
- Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) < 60 mL/min
- Pregnancy or lactation
- Women actively being treated for cancer of any type with chemotherapy
- Currently or previously on metformin for any medical condition
- Multiple allergies or severe asthma treated with medication
- Having only one kidney
- High blood pressure
- Serious allergic reaction to any substance
I. To show in a prospective clinical trial that, in women with a personal history of breast cancer, contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false positives.
I. Complete a reader validation study at the conclusion of accrual (planned for year 2 of this project).
Within 8 weeks of standard of care (SOC) digital tomosynthesis mammography (preferably on the same day), patients receive iopamidol intravenously (IV), then undergo bilateral contrast-enhanced imaging (CEM) over 8-15 minutes.
After completion of study, patients are followed up for 1 year.
Trial Phase Phase III
Trial Type Screening
UPMC-Magee Womens Hospital
Wendie A. Berg
- Primary ID HCC 20-198
- Secondary IDs NCI-2020-11525
- Clinicaltrials.gov ID NCT04085510