Comparison of Synthetic Mammography Versus Full-Field Digital Mammography in Image Interpretation and Performance Metrics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electronic Health Record Review.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Electronic Health Record Review
Review of medical records and past imaging examinations
Primary outcome measures
- 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]
Eligibility criteria
Inclusion criteria
- Female
- Age 18 or older
- Consecutive cases in breast imaging center
Exclusion criteria
- Cases demonstrate administrative or technical errors (e.g. missing views, labeling inconsistent with report, etc.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT05056818 · 2020-0974 · NCI-2021-08879 · 2020-0974