Recruiting
Biennial CEM in Women With a Personal History of Breast Cancer
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.
ClinicalTrials.gov IDNCT06105749
PhaseNA
Enrollment1600
SponsorWendie Berg
Age30 Years
SexFEMALE
Conditions studied
Breast Cancer, Breast Neoplasms, Breast Cancer Female, Neoplasms
About this 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.
Interventions
- Device: contrast-enhanced mammography — Contrast-enhanced mammography (CEM) is a new FDA-approved exam that is similar to magnetic resonance imaging (MRI) in depicting breast cancers due to increased and leaky blood vessels. Contrast-enhanced mammography is used as an adjunct following mammography and/or ultrasound examinations to localize a known or suspected lesion.
Primary outcomes
- Incremental Cancer Detection Rate (at 24 months, 48 months, and 62 months)
- False-positive recall rate (at 24 months, 48 months, and 62 months)
- Positive-predictive values (at 24 months, 48 months, and 62 months)
Eligibility information
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
Study locations
- UPMC Magee-Womens Imaging - Bethel Park, Bethel Park, Pennsylvania 15102 United States
- UPMC Magee at the Lemieux Sports Complex, Cranberry Township, Pennsylvania 16066 United States
- Magee Womancare Monroeville, Monroeville, Pennsylvania 15146 United States
- Magee-Womens Hospital, Pittsburgh, Pennsylvania 15213 United States
- Hillman Cancer Center at Shadyside, Pittsburgh, Pennsylvania 15232 United States
- UPMC West Mifflin Outpatient Center, West Mifflin, Pennsylvania 15236 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-01.