Biennial contrast-enhanced mammography for women with a history of breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of biennial contrast-enhanced mammography (CEM) combined with annual digital breast tomosynthesis (DBT) in improving breast cancer detection rates among women with a personal history of breast cancer. Participants will undergo a baseline CEM exam alongside their routine DBT and will have follow-up CEM exams at 24 and 48 months. The study will compare the detection rates and false-positive rates of this combined approach to the standard annual DBT alone. Two radiologists will interpret the results to ensure accurate assessments.

Why it matters

Who can join: the full rules

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's running

• UPMC Magee-Womens Imaging - Bethel Park
  Bethel Park, Pennsylvania, United States Recruiting
• UPMC Magee at the Lemieux Sports Complex
  Cranberry Township, Pennsylvania, United States Recruiting
• Magee Womancare Monroeville
  Monroeville, Pennsylvania, United States Recruiting
• Magee-Womens Hospital
  Pittsburgh, Pennsylvania, United States Recruiting
• Hillman Cancer Center at Shadyside
  Pittsburgh, Pennsylvania, United States Recruiting
• UPMC West Mifflin Outpatient Center
  West Mifflin, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Wendie Berg, MD, PhD — University of Pittsburgh
• Study coordinator: Wendie Berg, MD, PhD
• Email: bergwa@upmc.edu
• Phone: 412-641-8278

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.