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)
1 other identifier
interventional
1,500
1 country
6
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 minimal increase in false-positives, in women with a personal history of breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Nov 2023
Longer than P75 for not_applicable breast-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2023
CompletedFirst Posted
Study publicly available on registry
October 30, 2023
CompletedStudy Start
First participant enrolled
November 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2031
September 11, 2025
September 1, 2025
6.1 years
October 23, 2023
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (1)
contrast-enhanced mammography
EXPERIMENTALEnrolled 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wendie Berglead
- Breast Cancer Research Foundationcollaborator
Study Sites (6)
UPMC Magee-Womens Imaging - Bethel Park
Bethel Park, Pennsylvania, 15102, United States
UPMC Magee at the Lemieux Sports Complex
Cranberry Township, Pennsylvania, 16066, United States
Magee Womancare Monroeville
Monroeville, Pennsylvania, 15146, United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
Hillman Cancer Center at Shadyside
Pittsburgh, Pennsylvania, 15232, United States
UPMC West Mifflin Outpatient Center
West Mifflin, Pennsylvania, 15236, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wendie Berg, MD, PhD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Radiology
Study Record Dates
First Submitted
October 23, 2023
First Posted
October 30, 2023
Study Start
November 8, 2023
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
April 1, 2031
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- At study conclusion starting immediately after publication and until indefinitely.
- 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.
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.