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Trial Title:
Clinical Data Collection in Breast Tomosynthesis (COBRIS)
NCT ID:
NCT05914168
Condition:
Breast Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Breast Tomosynthesis
Description:
Three dimensional mammography
Arm group label:
Study arm
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.
Criteria for 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
Gender:
Female
Gender based:
Yes
Gender description:
Women
Minimum age:
35 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Country:
France
Status:
Recruiting
Contact:
Last name:
Corinne Balleyguier, MD
Start date:
February 15, 2023
Completion date:
February 2024
Lead sponsor:
Agency:
GE Healthcare
Agency class:
Industry
Source:
GE Healthcare
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05914168
