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NCT05615298 Clinical Trial

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

Breast Cancer Clinical Trial

Official title:
Multi-reader, Multi-case, Observer-blind, Retrospective, Pivotal Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer During Screening Mammography Interpretation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05615298
Other study ID # LUN_MMG_121
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2020
Est. completion date January 13, 2021

Study information
Verified date November 2022
Source Lunit Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date January 13, 2021
Est. primary completion date January 13, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Mammography
FFDM (Full-Field Digital mammography)

Locations
Country Name City State
United States Atrius Health Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Lunit Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve to measure the effectiveness of Investigational Device between CAD assited and unassisted environment Through study completion, an average of 6 months
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