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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female

Age 18 or older

Consecutive cases in breast imaging center

Disqualifiers

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

Trial population

Patients who have undergo mammography between August 1, 2018 and August 31, 2020

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Electronic Health Record Review

    Other intervention

    Review of medical records and past imaging examinations

Treatment groups

750 Participants
are divided into 1 treatment group
Group A: Observational (medical records)1 intervention

Trial outcomes

Primary outcomes

1

To analyze the impact of synthetic mammography (SM), as compared with full-field digital mammography (FFDM

Time frame
through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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