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

NCT05716958 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 262

Last updated 2024-09-19

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Lunit Inc.

    lead INDUSTRY

Principal Investigators

  • Kihwan Kim, MD · Lunit Inc.

Eligibility

Min Age
22 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2023-02-28
Completion
2023-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05716958 on ClinicalTrials.gov