Breast Cancer
Conditions
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.
Interventions
DEVICEBreast Tomosynthesis
Three dimensional mammography
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data Collection | 1 year | Collect clinical breast images obtained with the investigational application. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
Primary ContactJean-Paul Antonini
Backup ContactRazvan Iordache
Outcome results
None listed