Clinical Data Collection in Breast Tomosynthesis (COBRIS)

General Electric (GE)

Status: Enrolling

Conditions: Breast Cancer

Treatments: Device: Breast Tomosynthesis

Study type: Interventional

Funder types: Industry

Identifiers

NCT05914168

179549298

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Study arm

Experimental group

Description:

Subjects with investigational acquisition

Treatment:

Device: Breast Tomosynthesis