Clinical Data Collection in Breast Tomosynthesis (COBRIS) (COBRIS)

Clinical Data Collection in Breast Tomosynthesis: COBRIS

The purpose of the study is to assess an image acquisition application for breast tomosynthesis in a clinical environment

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Breast Tomosynthesis

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will undergo their routine mammography examination. One additional mammography view will be obtained with the investigational application and analyzed. Subject participation is expected to last no more than 30 minutes. After the mammography examination, subjects will be followed according to the hospital standard of care.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Paul Antonini; Phone Number: +33 6 87706729; Email: jean-paul.antonini@ge.com
• Study Contact Backup: Name: Razvan Iordache; Phone Number: + 33 6 14199082; Email: razvan.iordache@med.ge.com

Study Locations

• France
  • Villejuif, France
    • Recruiting
    • Gustave Roussy
    • Contact: Corinne Balleyguier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women aged 35 years or older;
• Women referred for unilateral or bilateral 2D and 3D mammography;
• Women able and willing to comply with study procedures;
• Women able and willing to participate in this study who have signed and dated the informed consent form; and
• Women surgically sterile or postmenopausal or, the possibility of pregnancy is ruled out based on a negative urine pregnancy test

Exclusion Criteria:

• Women who have been previously included in this study; or
• Be a minor, protected adult, adult deprived of liberty by judicial or administrative decision, pregnant, parturient or a breastfeeding mother; or
• Women with BRCA 1 or BRCA 2 gene mutation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study arm; Subjects with investigational acquisition	Device: Breast Tomosynthesis; Three dimensional mammography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data Collection	Collect clinical breast images obtained with the investigational application.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Image Quality	Assess image quality through subjective and open expert evaluation of patient motion, visibility of replication artefacts and visibility of clinical findings.	1 year

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Balleyguier, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 179549298

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: No