NCT05716958

Multi-Reader, Multi-Case, Cross-Over, Retrospective Study to Evaluate Effectiveness of Lunit INSIGHT DBT

Multi-Reader, Multi-Case, Cross-Over, Retrospective, Superiority, Pivotal Study to Evaluate Effectiveness of Lunit INSIGHT DBT in the Assistance of Detection and Diagnosis of Breast Cancer During 3D Mammography Interpretation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 262 (actual)
• Sponsor: Lunit Inc. · Industry
• Sex: Female
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate Effectiveness of Lunit INSIGHT DBT in the assistance of detection and diagnosis of breast cancer during 3D mammography interpretation

Detailed description

The primary objective of the trial is to evaluate the effectiveness of Lunit INSIGHT DBT in the assistance of detection and diagnosis of breast cancer by comparing the clinical performance of radiologists before and after using Lunit INSIGHT DBT in their DBT reading and secondarily examining the use of Lunit INSIGHT DBT to shorten DBT reading time.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Digital Breast Tomosynthesis	Digital Breast Tomosynthesis (DBT) is a type of 3D mammography that creates detailed images of the breast tissue. It uses X-rays to take multiple images at different angles and combines them to create a clear, layered view of the breast tissue. DBT is used for breast cancer screening and diagnosis and provides a more accurate view of the breast tissue compared to traditional 2D mammography.

Timeline

• Start date: 2022-03-22
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2023-02-08
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study