Life sciences · Observational Study
ClinicalTrials.gov · October 6, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT05056818). This is a study registration, not published results. Lead sponsor: M.D. Anderson Cancer Center. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 750 participants (ESTIMATED). Conditions: Breast Carcinoma. Interventions: OTHER: Electronic Health Record Review. Primary outcome measures: To analyze the impact of synthetic mammography (SM), as compared with full-field digital mammography (FFDM , through study completion, an average of 1 year. Brief summary: This study compares synthetic mammography to full-field digital mammography in image interpretation and performance metrics. Digital breast tomosynthesis (DBT) has previously been found to be superior in performance to standard digital mammography in both screening and diagnostic settings for the early detection and improved diagnosis of breast cancers. DBT in combination with full-field digital mammography (FFDM) reduces recall rates and increases cancer detection rates relative to FFDM alone. Synthetic mammography is a 2-dimensional reconstructed image, using the dataset derived from the DBT acquisition, without requiring additional radiation dose. Collecting information from patients' medical records may help doctors analyze the characteristics, utility, and impact of synthetic mammography to compared to FFDM.