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

Lunit

Status: Completed

Conditions: Breast Cancer

Treatments: Radiation: Mammography

Study type: Observational

Funder types: Industry

Identifiers

NCT05615298

LUN_MMG_121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

240 participants in 2 patient groups

Cancer

Description:

* Negative image data: Has been interpreted as negative in screening mammograms * Benign image data: Has a suspicious lesion for breast cancer in screening mammograms but confirmed as a benign through the follow-up biopsy or has been interpreted as a benign in screening mammograms and confirmed as a benign in the further diagnostic images taken after at least two years from the screening mammograms.

Treatment:

Radiation: Mammography

Non-cancer

Description:

Has a suspicious lesion for breast cancer in screening mammograms and confirmed as a cancer (malignant) through the follow-up biopsy.

Treatment:

Radiation: Mammography