Recruiting

Synthetic Mammography vs. Digital Mammography

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05056818

Conditions

Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electronic Health Record Review

Study Details

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.

Conditions

Breast Carcinoma

Study ID

NCT05056818

Start date

Dec 15, 2020

Status verified date

Apr, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (medical records)

Patients' medical records and past imaging examinations are reviewed.

Interventions

Electronic Health Record Review

Review of medical records and past imaging examinations

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 and Locations

Central contacts

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Ray C. Mayo

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-16.