Biennial CEM in Women With a Personal History of Breast Cancer

NCT ID: NCT06105749

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-08
• Study Completion Date: 2031-04-30

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.

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).

Conditions

Breast Cancer; Breast Neoplasms; Breast Cancer Female; Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

contrast-enhanced mammography

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Breast Cancer Research Foundation

OTHER

Sponsor Role: collaborator

Wendie Berg

OTHER

Sponsor Role: lead

Responsible Party

Wendie Berg

Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wendie Berg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Magee-Womens Imaging - Bethel Park

Bethel Park, Pennsylvania, United States

Site Status: RECRUITING

UPMC Magee at the Lemieux Sports Complex

Cranberry Township, Pennsylvania, United States

Site Status: RECRUITING

Magee Womancare Monroeville

Monroeville, Pennsylvania, United States

Site Status: RECRUITING

Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Hillman Cancer Center at Shadyside

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

UPMC West Mifflin Outpatient Center

West Mifflin, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Wendie Berg, MD, PhD

Role: CONTACT

bergwa@upmc.edu

412-641-8278

McKenna Rigling, MS

Role: CONTACT

riglingmm@upmc.edu

412-641-8278

Facility Contacts

McKenna Rigling, MS

Role: primary

riglingmm@upmc.edu

412-641-8278

Maegan Johnson, RN

Role: backup

johnsonme15@upmc.edu

412-641-8283

McKenna Rigling, MS

Role: primary

riglingmm@upmc.edu

412-641-8278

Maegan Johnson, RN

Role: backup

johnsonme15@upmc.edu

412-641-8283

McKenna Rigling, MS

Role: primary

riglingmm@upmc.edu

412-641-8278

Maegan Johnson, RN

Role: backup

johnsonme15@upmc.edu

412-641-8283

McKenna Rigling, MS

Role: primary

riglingmm@upmc.edu

412-641-8278

Maegan Johnson, RN

Role: backup

johnsonme15@upmc.edu

412-641-8283

McKenna Rigling, MS

Role: primary

riglingmm@upmc.edu

412-641-8278

Maegan Johnson, RN

Role: backup

johnsonme15@upmc.edu

412-641-8283

McKenna Rigling, MS

Role: primary

riglingmm@upmc.edu

412-941-8278

Maegan Johnson, RN

Role: backup

johnsonme15@upmc.edu

412-641-8283

Other Identifiers

STUDY23080183

Identifier Type: -

Identifier Source: org_study_id