Clinical Data Collection in Breast Tomosynthesis (COBRIS)

Breast Cancer Clinical Trial

— COBRIS  

Official title:

Clinical Data Collection in Breast Tomosynthesis: COBRIS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05914168
• Other study ID #: 179549298
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: February 2024

Study information

• Verified date: June 2023
• Source: GE Healthcare
• Contact: Jean-Paul Antonini
• Phone: +33 6 87706729
• Email: jean-paul.antonini[@]ge.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Breast Tomosynthesis
Three dimensional mammography

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data Collection	Collect clinical breast images obtained with the investigational application.	1 year
Secondary	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