Breast Cancer Clinical Trial

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Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer

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Summary

This study aims to evaluate Effectiveness of Investigational Device, Lunit INSIGHT MMG, in the assistance of Detection and Diagnosis of Breast Cancer during Screening Mammography Interpretation.

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Full Description

The Lunit INSIGHT MMG is developed as a computer-assisted detection/diagnosis device based on deep learning technology. In this pivotal study, effectiveness of the investigational device, Lunit INSIGHT MMG, was examined by comparing the reading panelist's interpretation ability between CAD assisted and unassisted during screening mammography interpretation.

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Eligibility Criteria

Inclusion Criteria:

Female
Any ethnic origin
Acquired with devices from two manufacturers: Hologic and GE
4 views (RMLO, LMLO, RCC, LCC) images of FFDM (Full-Field Digital mammography)

Exclusion Criteria:

Previous core needle biopsy in breast for past 2 years
Previous vacuum-assisted biopsy, surgical biopsy or surgery in breast
Previous breast cancer
Lactating when taking screening mammograms
Presence of a breast implant in screening mammograms
Presence of a pacemaker in screening mammograms
Inadequate quality status such as insufficient anatomical coverage of screening mammograms

Study is for people with:

Breast Cancer

Estimated Enrollment:

240

Study ID:

NCT05615298

Recruitment Status:

Completed

Sponsor:

Lunit Inc.

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There is 1 Location for this study

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Atrius Health
Boston Massachusetts, 02215, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

240

Study ID:

NCT05615298

Recruitment Status:

Completed

Sponsor:


Lunit Inc.

How clear is this clinincal trial information?

Clinical Trial Resources

SurvivorNet’s Guide To Clinical Trials: What Are They And Are They Right for You?
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