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

NCT ID: NCT05056818

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-15

Study Completion Date

2026-10-31

Brief Summary

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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

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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.

Conditions

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Breast Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Observational (medical records)

Patients' medical records and past imaging examinations are reviewed.

Electronic Health Record Review

Intervention Type OTHER

Review of medical records and past imaging examinations

Interventions

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Electronic Health Record Review

Review of medical records and past imaging examinations

Intervention Type OTHER

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ray C Mayo

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ray C Mayo, MD

Role: CONTACT

713-745-4555

Facility Contacts

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Ray C. Mayo

Role: primary

713-745-4555

Related Links

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http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

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NCI-2021-08879

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-0974

Identifier Type: OTHER

Identifier Source: secondary_id

2020-0974

Identifier Type: -

Identifier Source: org_study_id

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