Actively Recruiting

Phase Not Applicable
Age: 30Years - 79Years
FEMALE
Healthy Volunteers
NCT06105749

Biennial CEM in Women With a Personal History of Breast Cancer

Led by Wendie Berg · Updated on 2025-09-11

1500

Participants Needed

6

Research Sites

385 weeks

Total Duration

On this page

Sponsors

W

Wendie Berg

Lead Sponsor

B

Breast Cancer Research Foundation

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Biennial CEM in Women With a Personal History of Breast Cancer

Who Can Participate

Age: 30Years - 79Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Asymptomatic women aged 30 to 79 years
  • Personal history of breast cancer
  • At least one year since any breast cancer surgery or treatment
  • Scheduled for routine annual mammogram with digital breast tomosynthesis (DBT)
Not Eligible

You will not qualify if you...

  • History of moderate or severe iodinated contrast reaction
  • Allergy to Benadryl if premedication is required
  • Breast implants in the breasts to be screened
  • Bilateral mastectomy
  • History of kidney failure or estimated glomerular filtration rate (eGFR) less than 45 mL/min
  • Pregnancy or lactation
  • Currently receiving chemotherapy for any cancer
  • Having only one kidney
  • Stage 4 metastasis to visceral areas or brain
  • Screening breast MRI exam within 24 months prior to current CEM exam
  • Contrast-enhanced mammography exam within prior 23 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

UPMC Magee-Womens Imaging - Bethel Park

Bethel Park, Pennsylvania, United States, 15102

Actively Recruiting

2

UPMC Magee at the Lemieux Sports Complex

Cranberry Township, Pennsylvania, United States, 16066

Actively Recruiting

3

Magee Womancare Monroeville

Monroeville, Pennsylvania, United States, 15146

Actively Recruiting

4

Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

5

Hillman Cancer Center at Shadyside

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

6

UPMC West Mifflin Outpatient Center

West Mifflin, Pennsylvania, United States, 15236

Actively Recruiting

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Research Team

W

Wendie Berg, MD, PhD

CONTACT

M

McKenna Rigling, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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Biennial CEM in Women With a Personal History of Breast Cancer | DecenTrialz