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

Multi-Reader, Multi-Case, Cross-Over, Retrospective, Superiority, Pivotal Study to Evaluate Effectiveness of Lunit INSIGHT DBT in the Assistance of Detection and Diagnosis of Breast Cancer During 3D Mammography Interpretation

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Digital Breast Tomosynthesis

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 262

Contacts and Locations

• Study Contact: Name: Ryan Choi, MS; Phone Number: +82-2-2138-0827; Email: ryan.choi@lunit.io

Study Locations

• United States
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Recruiting
      • Anne Arundel Medical Center
      • Contact: Julie Oda, MD; Phone Number: 254-654-2908; Email: joda@aah.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Mainly from a tertiary hospital but no limitation of enrollment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of Lunit INSIGHT DBT	Patient-level LOS (Level of Suspicion) area under the ROC (Receiver Operating Characteristic) curve	3 months after the 1st tomosynthesis reading

Collaborators and Investigators

• Sponsor: Lunit Inc.
• Investigators: Study Director: Kihwan Kim, MD, Lunit Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 22, 2022
• Primary Completion (ANTICIPATED): February 28, 2023
• Study Completion (ANTICIPATED): February 28, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: LUN_DBT_121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No