Biennial CEM in Women With a Personal History of Breast Cancer

Outcome of Biennial Screening Contrast-Enhanced Mammography (CEM) in Women With a Personal History of Breast Cancer (PHBC)

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Breast Cancer; Breast Neoplasms; Breast Cancer Female
• Intervention / Treatment: Device: contrast-enhanced mammography

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 fewer false positives than from annual DBT plus CEM. The investigators will offer biennial CEM exams for eligible patients. Enrolled participants will have a baseline CEM exam with their routine DBT exam, and then have another CEM exam 24 months after their baseline CEM exam and then again at 48 months. Participants will continue to have their annual DBT exams during this time as a part of their usual care. Two radiologists (one primary) will evaluate each pair of examinations by sequentially interpreting each of DBT and CEM in opposing order (primary reader DBT then CEM and secondary reader CEM then DBT), initially blinded to the other modality. We expect that with biennial screening, at least a similar number of cancers will be detected with CEM (and possibly more that were occult on the DBT-only screen 12 months prior), with a similar incremental false-positive rate and at least similar (if not improved) overall positive predictive value (PPV1).

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wendie Berg, MD, PhD; Phone Number: 412-641-8278; Email: bergwa@upmc.edu
• Study Contact Backup: Name: McKenna Rigling, MS; Phone Number: 412-641-8278; Email: riglingmm@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Bethel Park, Pennsylvania, United States, 15102
      • Recruiting
      • UPMC Magee-Womens Imaging - Bethel Park
      • Principal Investigator: Wendie Berg, MD, PhD
      • Contact: McKenna Rigling, MS; Phone Number: 412-641-8278; Email: riglingmm@upmc.edu
      • Contact: Maegan Johnson, RN; Phone Number: 412-641-8283; Email: johnsonme15@upmc.edu
    • Cranberry Township, Pennsylvania, United States, 16066
      • Recruiting
      • UPMC Magee at the Lemieux Sports Complex
      • Principal Investigator: Wendie Berg, MD, PhD
      • Contact: McKenna Rigling, MS; Phone Number: 412-641-8278; Email: riglingmm@upmc.edu
      • Contact: Maegan Johnson, RN; Phone Number: 412-641-8283; Email: johnsonme15@upmc.edu
    • Monroeville, Pennsylvania, United States, 15146
      • Recruiting
      • Magee Womancare Monroeville
      • Principal Investigator: Wendie Berg, MD, PhD
      • Contact: McKenna Rigling, MS; Phone Number: 412-641-8278; Email: riglingmm@upmc.edu
      • Contact: Maegan Johnson, RN; Phone Number: 412-641-8283; Email: johnsonme15@upmc.edu
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • Magee-Womens Hospital
      • Principal Investigator: Wendie Berg, MD, PhD
      • Contact: McKenna Rigling, MS; Phone Number: 412-641-8278; Email: riglingmm@upmc.edu
      • Contact: Maegan Johnson, RN; Phone Number: 412-641-8283; Email: johnsonme15@upmc.edu
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • Hillman Cancer Center at Shadyside
      • Principal Investigator: Wendie Berg, MD, PhD
      • Contact: McKenna Rigling, MS; Phone Number: 412-641-8278; Email: riglingmm@upmc.edu
      • Contact: Maegan Johnson, RN; Phone Number: 412-641-8283; Email: johnsonme15@upmc.edu
    • West Mifflin, Pennsylvania, United States, 15236
      • Recruiting
      • UPMC West Mifflin Outpatient Center
      • Principal Investigator: Wendie Berg, MD, PhD
      • Contact: Maegan Johnson, RN; Phone Number: 412-641-8283; Email: johnsonme15@upmc.edu
      • Contact: McKenna Rigling, MS; Phone Number: 412-941-8278; Email: riglingmm@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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) < 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: contrast-enhanced mammography; Enrolled participants will receive a baseline contrast-enhanced mammography exam for breast cancer screening, along with their scheduled 3D mammography exam, then they will receive another CEM exam for breast cancer screening at 24 months after their baseline CEM exam, and then again at 48 months. All the while, participants will still receive their annual 3D mammography exam as per their usual routine care.

Device: contrast-enhanced mammography; Contrast-enhanced mammography (CEM) is a new FDA-approved exam that is similar to magnetic resonance imaging (MRI) in depicting breast cancers due to increased and leaky blood vessels. Contrast-enhanced mammography is used as an adjunct following mammography and/or ultrasound examinations to localize a known or suspected lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental Cancer Detection Rate	CEM cancer detection rate for first observer vs usual care (annual DBT)	at 24 months, 48 months, and 62 months
False-positive recall rate	CEM false-positive findings for first observer vs usual care (annual DBT)	at 24 months, 48 months, and 62 months
Positive-predictive values	CEM positive-predictive values for first observer vs usual care (annual DBT)	at 24 months, 48 months, and 62 months

Collaborators and Investigators

• Sponsor: Wendie Berg
• Collaborators: Breast Cancer Research Foundation
• Investigators: Principal Investigator: Wendie Berg, MD, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): April 1, 2031

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Digital Breast Tomosynthesis; Breast cancer screening; Contrast-Enhanced Mammogram
• Additional Relevant MeSH Terms: Neoplasms by Site; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Neoplasms; Breast Neoplasms
• Other Study ID Numbers: STUDY23080183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Images may be shared with secondary investigators, including commercial companies after removal of all identifiers. All participant identification (name, patient number, birth date) will be removed prior to sharing.
• IPD Sharing Time Frame: At study conclusion starting immediately after publication and until indefinitely.
• IPD Sharing Access Criteria: Participant imaging may be shared with secondary investigators, including commercial companies either by electronic transfers or via disc downloads. All participant identification will be removed prior to the images release.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No