Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer
NCT ID: NCT05615298
Last Updated: 2022-11-14
Study Results
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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COMPLETED
240 participants
OBSERVATIONAL
2020-06-15
2021-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cancer
* Negative image data: Has been interpreted as negative in screening mammograms
* Benign image data: Has a suspicious lesion for breast cancer in screening mammograms but confirmed as a benign through the follow-up biopsy or has been interpreted as a benign in screening mammograms and confirmed as a benign in the further diagnostic images taken after at least two years from the screening mammograms.
Mammography
FFDM (Full-Field Digital mammography)
Non-cancer
Has a suspicious lesion for breast cancer in screening mammograms and confirmed as a cancer (malignant) through the follow-up biopsy.
Mammography
FFDM (Full-Field Digital mammography)
Interventions
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Mammography
FFDM (Full-Field Digital mammography)
Eligibility Criteria
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Inclusion Criteria
* 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 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
FEMALE
Yes
Sponsors
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Lunit Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gregg Miller, MD
Role: PRINCIPAL_INVESTIGATOR
Atrius Health
Locations
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Atrius Health
Boston, Massachusetts, United States
Countries
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Other Identifiers
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LUN_MMG_121
Identifier Type: -
Identifier Source: org_study_id
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