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

Recruiting

• Conditions: Breast Carcinoma
• Interventions: Other: Electronic Health Record Review

• Registration Number: NCT05056818
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-12-15
• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15
• Primary Completion: 2026-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 750

Inclusion Criteria

• Female
• Age 18 or older
• Consecutive cases in breast imaging center

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Exclusion Criteria

• Cases demonstrate administrative or technical errors (e.g. missing views, labeling inconsistent with report, etc.)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (medical records)	Electronic Health Record Review	Patients' medical records and past imaging examinations are reviewed.

Primary Outcome Measures

Name	Time	Method
To analyze the impact of synthetic mammography (SM), as compared with full-field digital mammography (FFDM	through study completion, an average of 1 year

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States