Biennial CEM in Women With a Personal History of Breast Cancer
Recruiting · NCT06105749 · Interventional (participants receive a specific treatment) · Lead sponsor: Wendie Berg
View the official record on ClinicalTrials.gov →Interventions studied
contrast-enhanced mammography
What this trial is about
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.
Who can take part
Age range
30 Years to 79 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
6 locations listed across 1 US state.
- UPMC Magee-Womens Imaging - Bethel Park - Bethel Park, Pennsylvania, United States
- UPMC Magee at the Lemieux Sports Complex - Cranberry Township, Pennsylvania, United States
- Magee Womancare Monroeville - Monroeville, Pennsylvania, United States
- Magee-Womens Hospital - Pittsburgh, Pennsylvania, United States
- Hillman Cancer Center at Shadyside - Pittsburgh, Pennsylvania, United States
- UPMC West Mifflin Outpatient Center - West Mifflin, Pennsylvania, United States