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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

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