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NCT05056818 Clinical Trial

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

Breast Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05056818
Other study ID # 2020-0974
Secondary ID NCI-2021-0887920
Status Recruiting
Phase
First received
Last updated
Start date December 15, 2020
Est. completion date October 31, 2026

Study information
Verified date April 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date October 31, 2026
Est. primary completion date October 31, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Electronic Health Record Review
Review of medical records and past imaging examinations

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To analyze the impact of synthetic mammography (SM), as compared with full-field digital mammography (FFDM through study completion, an average of 1 year
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