Contrast-Enhanced Mammography for the Improvement of Surveillance in Women with a Personal History of Breast Cancer

This phase III trial investigates how a contrast-enhanced mammogram works in improving screening of women with a history of breast cancer who may be inadequately scanned by mammography alone. The contrast enhancement consists of injecting an iodine-containing “dye” into the bloodstream that allows researchers to better see masses that may represent cancer in the breasts. Results of this study may indicate earlier breast cancer detection and less invasive treatment than if the cancer were detected as part of usual care.

Inclusion Criteria

• Asymptomatic women, ages 30-85, with a personal history of breast cancer who have had at least one routine mammogram since treatment

Exclusion Criteria

• 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

PRIMARY OBJECTIVE:

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.

SECONDARY OBJECTIVE:

I. Complete a reader validation study at the conclusion of accrual (planned for year 2 of this project).

OUTLINE:

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

Lead Organization
UPMC-Magee Womens Hospital

Principal Investigator
Wendie A. Berg

• Primary ID HCC 20-198
• Secondary IDs NCI-2020-11525
• Clinicaltrials.gov ID NCT04085510