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

Completed

• Conditions: Breast Cancer
• Interventions: Radiation: Mammography

• Registration Number: NCT05615298
• Lead Sponsor: Lunit Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-06-15
• Primary Completion: 2021-01-13
• Study Completion: 2021-01-13
• Status Verified: 2022-11
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Study First Posted: 2022-11-14
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer	Mammography	* 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.
Non-cancer	Mammography	Has a suspicious lesion for breast cancer in screening mammograms and confirmed as a cancer (malignant) through the follow-up biopsy.

Primary Outcome Measures

Name	Time	Method
Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve	Through study completion, an average of 6 months	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

Trial Locations

Locations (1)

Atrius Health; 🇺🇸 Boston, Massachusetts, United States