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ACTIVE NOT RECRUITING
NCT05046301

Contrast-Enhanced Mammography for the Evaluation of Mammographic Microcalcifications

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Official title: Contrast-Enhanced Mammography (CEM) and CEM-Directed Biopsy for the Evaluation of Extensive Suspicious Mammographic Microcalcifications

Key Details

Gender

FEMALE

Age Range

25 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

59

Start Date

2021-03-23

Completion Date

2027-02-02

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Correlative studies

OTHER

Contrast Agent

Given IV

PROCEDURE

Contrast-Enhanced Mammography

Undergo contrast-enhanced mammography

OTHER

Questionnaire Administration

Ancillary studies

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States