Biennial CEM in Women With a Personal History of Breast Cancer
Recruiting now · Not applicable
Conditions studied: Breast Cancer, Breast Neoplasms, Breast Cancer Female, Neoplasms
In brief
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.
Key facts
- Study ID
- NCT06105749
- Run by
- Wendie Berg
- People needed
- 1500
- Starts
- 2023-11-08
- Expected to finish
- 2031-04-01
- Last updated by the study team
- 2025-09-11
Who can join
Age: 30 and older, up to 79. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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) < 45 mL/min
- Pregnancy or lactation
- Women actively being treated for cancer of any type with chemotherapy
- Having only one kidney
- Women with stage 4 metastasis to visceral areas or brain
- Women who have a screening breast MRI exam within 24 months prior to the current round of CEM.
- Women who had a CEM exam within the prior 23 months
Where it is running
- UPMC Magee-Womens Imaging - Bethel Park — Bethel Park, Pennsylvania, United States (enrolling)
- UPMC Magee at the Lemieux Sports Complex — Cranberry Township, Pennsylvania, United States (enrolling)
- Magee Womancare Monroeville — Monroeville, Pennsylvania, United States (enrolling)
- Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
- Hillman Cancer Center at Shadyside — Pittsburgh, Pennsylvania, United States (enrolling)
- UPMC West Mifflin Outpatient Center — West Mifflin, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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