Clinical Data Collection in Breast Tomosynthesis (COBRIS) | NCT05914168

Studies
Clinical Data Collection in Breast Tomosynthesis (COBRIS)

NCT05914168

Sponsor

GE Healthcare

Status

Unknown status

Last Update Posted

Jun 22, 2023Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Breast Tomosynthesis

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2023Actual

Primary Completion Date

Feb 2024Estimated

Completion Date

Feb 2024Estimated

First Submitted Date

Dec 13, 2022

First Submission Date that Met QC Criteria

Jun 19, 2023

First Posted Date

Jun 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2023

Last Update Posted Date

Jun 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study arm	Experimental	Subjects with investigational acquisition	Device: Breast Tomosynthesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breast Tomosynthesis	Device	Three dimensional mammography	Study arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Data Collection	Collect clinical breast images obtained with the investigational application.	1 year

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jean-Paul Antonini	Contact	+33 6 87706729		jean-paul.antonini@ge.com
Razvan Iordache	Contact	+ 33 6 14199082		razvan.iordache@med.ge.com

Overall Officials

Name	Affiliation	Role
Balleyguier	Gustave Roussy, Cancer Campus, Grand Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gustave Roussy	Recruiting	Villejuif			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008327	Mammography

Ancestor Terms

ID	Term
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided