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

Sponsor
Lunit Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05615298
Collaborator
(none)
240
Enrollment
1
Location
7
Actual Duration (Months)
34.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Mammography

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 Design

Study Type:
Observational
Actual Enrollment :
240 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
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
Actual Study Start Date :
Jun 15, 2020
Actual Primary Completion Date :
Jan 13, 2021
Actual Study Completion Date :
Jan 13, 2021

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Atrius Health Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Lunit Inc.

Investigators

  • Principal Investigator: Gregg Miller, MD, Atrius Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lunit Inc.
ClinicalTrials.gov Identifier:
NCT05615298
Other Study ID Numbers:
  • LUN_MMG_121
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Nov 14, 2022