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

Lunit

Status: Completed

Conditions: Breast Cancer

Treatments: Radiation: Digital Breast Tomosynthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT05716958

LUN_DBT_121

Details and patient eligibility

About

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

Full 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.

Enrollment: 262 patients

Sex: Female

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

[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.

Exclusion criteria

• 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

Trial design

262 participants in 2 patient groups

Cancer group

Description:

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.

Treatment:

Radiation: Digital Breast Tomosynthesis

Non-Cancer group

Description:

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.

Treatment:

Radiation: Digital Breast Tomosynthesis