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

November 9, 2022 updated by: Lunit Inc.

Multi-reader, Multi-case, Observer-blind, Retrospective, Pivotal Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer During Screening Mammography Interpretation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Atrius Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Screenign Mammography Population

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer
  • 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.
Radiation: Mammography
FFDM (Full-Field Digital mammography)
Non-cancer
Has a suspicious lesion for breast cancer in screening mammograms and confirmed as a cancer (malignant) through the follow-up biopsy.
Radiation: Mammography
FFDM (Full-Field Digital mammography)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve
Time Frame: Through study completion, an average of 6 months
Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve to measure the effectiveness of Investigational Device between CAD assited and unassisted environment
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lunit Inc.

Investigators

  • Principal Investigator: Gregg Miller, MD, Atrius Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

January 13, 2021

Study Completion (Actual)

January 13, 2021

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUN_MMG_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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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