Recruiting

Observational StudyBiennial CEM in Women With a Personal History of Breast Cancer

Sponsor:

Wendie Berg

Code:

NCT06105749

Conditions

Breast Cancer

Breast Neoplasms

Breast Cancer Female

Neoplasms

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Accepted

Interventions

contrast-enhanced mammography

Study Details

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.

Conditions

Breast Cancer

Breast Neoplasms

Breast Cancer Female

Neoplasms

Study ID

NCT06105749

Start date

Nov 8, 2023

Status verified date

Aug, 2026

Completion date

Apr, 2031

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1600 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

Incremental Cancer Detection Rate [ Time Frame: at 24 months, 48 months, and 62 months ]
False-positive recall rate [ Time Frame: at 24 months, 48 months, and 62 months ]
Positive-predictive values [ Time Frame: at 24 months, 48 months, and 62 months ]

Central Contacts and Locations

Central contacts

Wendie Berg, MD, PhD

412-641-8278 bergwa@upmc.edu

McKenna Rigling, MS

412-641-8278 riglingmm@upmc.edu

Locations

UPMC Magee-Womens Imaging - Bethel Park

Recruiting

Bethel Park, Pennsylvania, United States, 15102

Contacts

McKenna Rigling, MS

412-641-8278 riglingmm@upmc.edu

Maegan Johnson, RN

412-641-8283 johnsonme15@upmc.edu

Principal Investigator:

Wendie Berg, MD, PhD

UPMC Magee at the Lemieux Sports Complex

Recruiting

Cranberry Township, Pennsylvania, United States, 16066

Contacts

McKenna Rigling, MS

412-641-8278 riglingmm@upmc.edu

Maegan Johnson, RN

412-641-8283 johnsonme15@upmc.edu

Principal Investigator:

Wendie Berg, MD, PhD

Magee Womancare Monroeville

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

McKenna Rigling, MS

412-641-8278 riglingmm@upmc.edu

Maegan Johnson, RN

412-641-8283 johnsonme15@upmc.edu

Principal Investigator:

Wendie Berg, MD, PhD

Magee-Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

McKenna Rigling, MS

412-641-8278 riglingmm@upmc.edu

Maegan Johnson, RN

412-641-8283 johnsonme15@upmc.edu

Principal Investigator:

Wendie Berg, MD, PhD

Hillman Cancer Center at Shadyside

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

McKenna Rigling, MS

412-641-8278 riglingmm@upmc.edu

Maegan Johnson, RN

412-641-8283 johnsonme15@upmc.edu

Principal Investigator:

Wendie Berg, MD, PhD

UPMC West Mifflin Outpatient Center

Recruiting

West Mifflin, Pennsylvania, United States, 15236

Contacts

McKenna Rigling, MS

412-941-8278 riglingmm@upmc.edu

Maegan Johnson, RN

412-641-8283 johnsonme15@upmc.edu

Principal Investigator:

Wendie Berg, MD, PhD

More Information

Sponsor

Wendie Berg

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

Breast cancer screening
Digital Breast Tomosynthesis
Contrast-Enhanced Mammogram

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wendie Berg on 2026-08-19.