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Contrast-Enhanced Mammography for the Evaluation of Mammographic Microcalcifications

NCT05046301 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 59

Last updated 2026-02-25

No results posted yet for this study

Summary

This clinical trial evaluates the added role of contrast-enhanced mammography (CEM), as well as imaging and blood biomarkers, for predicting the presence or absence of high-grade ductal carcinoma in situ (DCIS) or invasive cancer on pathology. Screening mammography is the mainstay of population-wide early breast cancer detection, and mammography-detected cancers are usually of an earlier stage, giving women the best chance of survival. However, the main drawbacks of this type of screening are false positive results and potential over-diagnosis of breast cancer. Suspicious microcalcifications detected with mammography pose a particular diagnostic problem, as they may be associated with invasive and high-grade in-situ cancers like DCIS, but are more often benign or require further workup to verify diagnosis. As such, microcalcifications detected by mammography pose a risk of both over-diagnosis and underestimation of disease severity. This study evaluates the impact of using CEM, compared to standard full field digital mammography (FFDM) for the management of suspicious microcalcifications and prediction of breast cancer in women with this finding.

Conditions

  • Breast Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Correlative studies

OTHER

Contrast Agent

Given IV

PROCEDURE

Contrast-Enhanced Mammography

Undergo contrast-enhanced mammography

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Olena Weaver · M.D. Anderson Cancer Center

Eligibility

Min Age
25 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-23
Primary Completion
2027-02-02
Completion
2027-02-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05046301 on ClinicalTrials.gov