Collection of FUJIFILM's 3Dimensional Mammograms (3DM)

FujiFilm

Status: Completed

Conditions: Breast Cancer

Treatments: Device: 2D FFDM; Device: 3Dimensional Mammography

Study type: Observational

Funder types: Industry

Identifiers

NCT01542814

FMSU2011-003A

Details and patient eligibility

About

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.

Full description

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

Enrollment: 600 patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

600 participants in 2 patient groups

Fujifilm 3Dimensional Mammography

Description:

Group of subjects being given Fujifilm 3D Mammography Imaging

Treatment:

Device: 2D FFDM

2D FFDM

Description:

Group of Subjects receiving FujiFilm or other FDA Approved 2D Mammography Imaging

Treatment:

Device: 3Dimensional Mammography