Biennial CEM in Women With a Personal History of Breast Cancer

Last updated: September 4, 2025
Sponsor: Wendie Berg
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Cancer

Breast Cancer

Treatment

contrast-enhanced mammography

Clinical Study ID

NCT06105749
STUDY23080183
  • Ages 30-79
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Asymptomatic women, ages 30-79, with a personal history of breast cancer who are atleast one year out from any breast cancer surgery and/or treatment and are scheduledto have a routine annual mammogram with tomosynthesis (DBT).

Exclusion

Exclusion Criteria:

  • Women with a history of prior moderate or severe iodinated contrast reaction [onlythose with a prior mild reaction that can be managed by pre-medication AND with anda strong desire to participate will be allowed to participate. However, among thesewomen with a mild sensitivity, if they are allergic to Benadryl (one of thepremedications), they will be excluded].

  • Women with implant(s) in the breasts to be screened (as this creates artifacts anddiagnostic performance of imaging in women with implants likely does not generalizeto those without implants, and the sample size with implants would be too small toinfer 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 currentround of CEM.

  • Women who had a CEM exam within the prior 23 months

Study Design

Total Participants: 1500
Treatment Group(s): 1
Primary Treatment: contrast-enhanced mammography
Phase:
Study Start date:
November 08, 2023
Estimated Completion Date:
April 30, 2031

Study 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).

Connect with a study center

  • UPMC Magee-Womens Imaging - Bethel Park

    Bethel Park, Pennsylvania 15102
    United States

    Site Not Available

  • UPMC Magee at the Lemieux Sports Complex

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • Magee Womancare Monroeville

    Monroeville, Pennsylvania 15146
    United States

    Site Not Available

  • Magee-Womens Hospital

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • UPMC West Mifflin Outpatient Center

    West Mifflin, Pennsylvania 15236
    United States

    Site Not Available

  • UPMC Magee-Womens Imaging - Bethel Park

    Bethel Park 5180199, Pennsylvania 6254927 15102
    United States

    Active - Recruiting

  • UPMC Magee at the Lemieux Sports Complex

    Cranberry Township 8643098, Pennsylvania 6254927 16066
    United States

    Active - Recruiting

  • Magee Womancare Monroeville

    Monroeville 5201734, Pennsylvania 6254927 15146
    United States

    Active - Recruiting

  • Hillman Cancer Center at Shadyside

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Active - Recruiting

  • Magee-Womens Hospital

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Active - Recruiting

  • UPMC West Mifflin Outpatient Center

    West Mifflin 5218802, Pennsylvania 6254927 15236
    United States

    Active - Recruiting

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