Clinical Data Collection in Breast Tomosynthesis (COBRIS)

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Device: Breast Tomosynthesis

• Registration Number: NCT05914168
• Lead Sponsor: GE Healthcare

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-12-13
• Study Start: 2023-02-15
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-19
• Last Update Submitted: 2023-06-19
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	Breast Tomosynthesis	Subjects with investigational acquisition

Primary Outcome Measures

Name	Time	Method
Data Collection	1 year	Collect clinical breast images obtained with the investigational application.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, France