Clinical Data Collection in Breast Tomosynthesis: COBRIS

GE Healthcare1 site in 1 country150 target enrollmentFebruary 15, 2023

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: GE Healthcare
Enrollment: 150
Locations: 1
Primary Endpoint: Data Collection
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 15, 2023

End Date

February 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

GE Healthcare

Responsible Party

Sponsor

Eligibility Criteria

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