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Biennial CEM in Women With a Personal History of Breast Cancer
RecruitingHealthy volunteers welcome
Outcome of Biennial Screening Contrast-Enhanced Mammography (CEM) in Women With a Personal History of Breast Cancer (PHBC)
Who can join
Ages 30 to 79 · Women · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Asymptomatic women, ages 30-79, with a personal history of breast cancer who are at least one year out from any breast cancer surgery and/or treatment and are scheduled to have a routine annual mammogram with tomosynthesis (DBT). Exclusion Criteria: * Women with a history of prior moderate or severe iodinated contrast reaction \[only those with a prior mild reaction that can be managed by pre-medication AND with and a strong desire to participate will be allowed to participate. However, among these women with a mild sensitivity, if they are allergic to Benadryl (one of the premedications), they will be excluded\]. * 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) \< 30 mL/min * Pregnancy or lactation * Women actively being treated for cancer of any type with chemotherapy. * Women with stage 4 metastasis to visceral areas or brain * Women with known personal history of breast cancer who have a screening breast MRI exam within 24 months prior to the current round of CEM. * Women with known personal history of breast cancer who had a CEM exam within the prior 23 months
About the study
This is a prospective clinical trial that will examine if biennial contrast-enhanced mammography added to annual 3D mammography (tomosynthesis) substantially improves breast cancer detection with minimal increase in false-positives, in women with a personal history of breast cancer.
What is being tested
- contrast-enhanced mammography (device)
Sponsor: Wendie Berg · Participants: 1,600 · Started: Nov 8, 2023
Contact the study team
- Wendie Berg, MD, PhD · Phone: 412-641-8278
- McKenna Rigling, MS · Phone: 412-641-8278
Official record on ClinicalTrials.gov — NCT06105749
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.