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

NCT05615298 | Completed FDA Device

• 1 other identifier: LUN_MMG_121
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (2)

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

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

Interventions

Mammography RADIATION

FFDM (Full-Field Digital mammography)

Cancer; Non-cancer

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Screenign Mammography Population

You may qualify if:

• Female
• Any ethnic origin
• Acquired with devices from two manufacturers: Hologic and GE
• views (RMLO, LMLO, RCC, LCC) images of FFDM (Full-Field Digital mammography)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lunit Inc.: lead

Study Sites (1)

Atrius Health

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gregg Miller, MD

  Atrius Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 14, 2022
• Study Start: June 15, 2020
• Primary Completion: January 13, 2021
• Study Completion: January 13, 2021
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)