Contrast-Enhanced Mammography for the Evaluation of Mammographic Microcalcifications

Running, not enrolling

Conditions studied: Breast Carcinoma

In brief

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.

Key facts

Study ID

NCT05046301

Run by

M.D. Anderson Cancer Center

People needed

59

Starts

2021-03-23

Expected to finish

2027-02-02

Last updated by the study team

2026-02-25

Who can join

Age: 25 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women with suspicious mammographic microcalcifications (Breast Imaging Reporting and Data System [BI-RADS] categories 4 or 5) occupying an area equal to or exceeding 4 cm in diameter and recommended for a stereotactic biopsy, who underwent their diagnostic imaging work-up resulting in a biopsy recommendation at MD Anderson Cancer Center (MDACC) or at an outside facility with a technically acceptable quality of diagnostic mammography, and who are planning to have their stereotactic biopsy at MDACC.
• Age 25-85 years
• Willing to participate in the study, undergo an intravenous (IV) placement, able to undergo iodinated contrast injection, and able to provide informed consent

You may not qualify if…

• Reported history of an allergic reaction to iodinated contrast
• History of anaphylactic reaction to any substance that required hospitalization or IV placement in a patient with no known prior uneventful exposure to iodine-based IV contrast
• Renal insufficiency
• Pregnancy or lactation within 6 months
• Breast surgery affecting the site of interest within prior 6 months
• Breast biopsy at the site of interest within the last 2 months
• Mammographic mass or architectural distortion associated with the calcifications in question

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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