Biennial CEM in Women With a Personal History of Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-79
SponsorWendie Berg
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- contrast-enhanced mammography
Treatment groups
1,600 Participants
are divided into 1 treatment groupSponsors and collaborators
Wendie Berg
Lead sponsor
University of Pittsburgh
Sponsor institution
Breast Cancer Research Foundation
Collaborator
Source ClinicalTrials.gov