Real World Evaluation of Lunit INSIGHT MMG Technology

Launched by LUNIT INC. · Jan 22, 2024

Keywords

ClinConnect Summary

The study has three main objectives, which will be met through separate sub-studies and analyses.

First, it will investigate and compare the performance of the Lunit INSIGHT MMG tool in combination with a human reader, against the current standard of care (two human readers). Quantitative data will be collected from a prospective, observational cohort study which will take place during routine clinical care at the participating site in parallel to standard care. The main aims will be:

1. To assess and compare the sensitivity and specificity of Lunit INSIGHT MMG combined with a single huma...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Non-Inferiority Study
• • Women 18 years of age or older.
• • Referred to a "one-stop" breast clinic following GP appointment for breast symptoms.
• • Patient and workforce qualitative studies Patients: as above. Workforce: Clinical staff and other key stakeholders involved in the implementation of Lunit INSIGHT MMG both male and female
• • • Able to undergo mammography.
• Exclusion Criteria:
• • Non-Inferiority Study
• • Men will not be included in this study.
• • Women who are not able to tolerate a mammogram or are unable to have one due to physical difficulties in engagement with the technology caused by immobility or being wheelchair bound.
• • Patient and workforce qualitative studies Patients: as above. Workforce: Has no connection to Lunit INSIGHT MMG implementation irrespective of being male or female

Trial Officials