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

Completed

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT05716958

Run by

Lunit Inc.

People needed

262

Starts

2022-03-22

Expected to finish

2023-02-28

Last updated by the study team

2024-09-19

Who can join

Age: 22 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• [For All Subject Groups]
• Female
• 22 years old or older
• [For 'Control (Non-cancer)' Group]
• Negative Cases Interpreted as BI-RADS 0 (Assessment Incomplete) or BI-RADS 1 (Negative) with no cancers on the DBT exam and confirmed as BI-RADS 1 (Negative) on the further diagnostic imaging (e.g., MMG, DBT, MRI, CT and Ultrasound) taken at least after 1 year of the DBT exam.
• Benign Cases Interpreted as BI-RADS 0 (Assessment Incomplete) or BI-RADS 2 (Benign) with a visible lesion on the DBT exam and confirmed as BI-RADS 2 (Benign) on the further diagnostic imaging (e.g., MMG, DBT, MRI, CT and Ultrasound) taken at least after 1 year of the DBT exam without a further breast biopsy.
• Or for the biopsy-proven benign exams, interpreted as BI-RADS 0 (Assessment Incomplete), BI-RADS 3 (Probably Benign), 4 (Suspicious) or 5 (Highly Suggestive of Malignancy) with a visible suspicious lesion for breast cancer on the DBT exam but confirmed as benign through subsequent biopsy conducted within following 1 year of the DBT exam.
• [For 'Condition (Cancer)' Group] Interpreted as BI-RADS 0 (Assessment Incomplete), BI-RADS 3 (Probably Benign), 4 (Suspicious) or 5 (Highly Suggestive of Malignancy) with a visible suspicious lesion for breast cancer on the DBT exam and confirmed as a cancer (malignant) through the subsequent biopsy conducted within following 1 year of the DBT exam.

You may not qualify if…

• Previous breast cancer
• Previous vacuum-assisted biopsy, surgical biopsy or surgery in breast
• Presence of a breast implant or pacemaker on the required images: 4 views (RCC, RMLO, LCC, LMLO) images of Screening or diagnostic DBT exams with a FFDM (Full-Field Digital mammography) image or with a synthetic 2D image

Where it is running

• Anne Arundel Medical Center — Annapolis, Maryland, United States

Full record on ClinicalTrials.gov

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