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NCT Number: NCT05615298

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Atrius Health

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mammography

Radiation

FFDM (Full-Field Digital mammography)

Primary outcomes

  1. Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Lunit Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 14, 2022
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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