NCT05056818

Comparison of Synthetic Mammography Versus Full-Field Digital Mammography in Image Interpretation and Performance Metrics

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 750 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To analyze the characteristics, utility, and impact of synthetic mammography (SM), as compared with full-field digital mammography (FFDM). OUTLINE: Patients' medical records and past imaging examinations are reviewed.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Electronic Health Record Review	Review of medical records and past imaging examinations

Timeline

• Start date: 2020-12-15
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2021-09-27
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States