Collection of FUJIFILM's 3Dimensional Mammograms

Completed

• Conditions: Breast Cancer
• Interventions: Device: 2D FFDM; Device: 3Dimensional Mammography

• Registration Number: NCT01542814
• Lead Sponsor: Fujifilm Medical Systems USA, Inc.

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

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-02
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-23
• Last Update Posted: 2013-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Female.
• 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fujifilm 3Dimensional Mammography	2D FFDM	Group of subjects being given Fujifilm 3D Mammography Imaging
2D FFDM	3Dimensional Mammography	Group of Subjects receiving FujiFilm or other FDA Approved 2D Mammography Imaging

Primary Outcome Measures

Name	Time	Method
Acquire screening cases with and without breast cancer.	18-months

Trial Locations

Locations (3)

Elizabeth Wende Breast Care, LLC (EWBC); 🇺🇸 Rochester, New York, United States

Emory University Healthcare; 🇺🇸 Atlanta, Georgia, United States

Scottsdale Medical Imaging, Limited (SMIL); 🇺🇸 Scottsdale, Arizona, United States