NCT05914168

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

12 months

First QC Date

December 13, 2022

Last Update Submit

June 19, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Data Collection

    Collect clinical breast images obtained with the investigational application.

    1 year

Secondary Outcomes (1)

  • Assessment of Image Quality

    1 year

Study Arms (1)

Study arm

EXPERIMENTAL

Subjects with investigational acquisition

Device: Breast Tomosynthesis

Interventions

Breast TomosynthesisDEVICE

Three dimensional mammography

Study arm

Eligibility Criteria

Age35 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy

Villejuif, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Balleyguier

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Paul Antonini

CONTACT

+33 6 87706729jean-paul.antonini@ge.com

Razvan Iordache

CONTACT

+ 33 6 14199082razvan.iordache@med.ge.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2022

First Posted

June 22, 2023

Study Start

February 15, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)