Status:
RECRUITING
Biennial CEM in Women With a Personal History of Breast Cancer
Lead Sponsor:
Wendie Berg
Collaborating Sponsors:
Breast Cancer Research Foundation
Conditions:
Breast Cancer
Breast Neoplasms
Eligibility:
FEMALE
30-79 years
Phase:
NA
Brief Summary
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 mini...
Detailed Description
The investigators seek to determine if improved breast cancer detection is maintained with biennial contrast-enhanced mammography (CEM) added to annual digital breast tomosynthesis (DBT) with overall ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2031
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06105749
Start Date
November 8 2023
End Date
April 1 2031
Last Update
September 11 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
UPMC Magee-Womens Imaging - Bethel Park
Bethel Park, Pennsylvania, United States, 15102
2
UPMC Magee at the Lemieux Sports Complex
Cranberry Township, Pennsylvania, United States, 16066
3
Magee Womancare Monroeville
Monroeville, Pennsylvania, United States, 15146
4
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213