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

Conditions

• Breast Carcinoma

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Electronic Health Record Review — OTHER
  Review of medical records and past imaging examinations

Study Details

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.

Key Dates

Start date

Dec 15, 2020

Status verified

Apr 2026

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

750 participants (estimated)

Arms

• Arm: Observational (medical records)
  Patients' medical records and past imaging examinations are reviewed.

Primary Outcome Measure

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 ]

Central Contacts

• Ray C Mayo, MD
  713-745-4555
  [email protected]

Locations (1)

Find similar trials in Houston, TX

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