Acquisition of Mammography Images for Clinical Evaluation of FUJIFILM 3Dimensional Mammography

Fujifilm Medical Systems USA, Inc.3 sites in 1 country600 target enrollmentFebruary 2012

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Fujifilm Medical Systems USA, Inc.
Enrollment: 600
Locations: 3
Primary Endpoint: Acquire screening cases with and without breast cancer.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This image-acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. The acquired data will be used to support FUJIFILM protocol FMSU2011-003B (Clinical Evaluation of FUJIFILM 3Dimensional Digital Mammography) and future regulatory submissions.

Detailed Description

This is an image acquisition reader study to observe differences between 3D FujiFilm Mammography and 2D approved Mammography

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

June 2013

Last Updated

12 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Fujifilm Medical Systems USA, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Any ethnic or racial origin.
•Must come through the study via the screening or diagnostic pathway described above.
•Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
•Meet none of the exclusion criteria.

Exclusion Criteria

•• Presence of a breast implant.
•Women with only a single breast; for example, post mastectomy patients.
•Is pregnant or believes she may be pregnant.
•A woman who has delivered and who has expressed the intention to breast-feed or is currently breast-feeding.
•A woman who has significant existing breast trauma.
•Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate mammography examinations.
•A woman who has had a mammogram performed for the purpose of therapy portal planning.
•Inadequate technical quality mammography images, such as insufficient anatomical coverage or significant motion artifacts.
•Cannot, for any known reason, undergo follow-up mammography examinations (where clinically indicated) at the participating institution.
•Is an inmate (see US Code of Federal Regulations 45CFR46.306).