Skip to main content
OpenTrials
Completed

NCT Number: NCT01542814

Collection of FUJIFILM's 3Dimensional Mammograms

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Scottsdale Medical Imaging, Limited (SMIL), Scottsdale, Arizona, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

3Dimensional Mammography

Device

The FUJIFILM 3DM examination is a 4-view mammogram which includes CC and MLO views of each breast. For each view, a routine (0-degree) mammogram will be acquired followed immediately in the same compression by a second mammogram offset at 4 degrees.

Other names: FUJIFILM 3Dimensional Mammography

2D FFDM

Device

Standard of care screening mammogram.

Primary outcomes

  1. Acquire screening cases with and without breast cancer.

    Time frame: 18-months

Sponsors and collaborators

Lead sponsor

Fujifilm Medical Systems USA, Inc.

Industry

Registry information

Official study title

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

Acronym: 3DM

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 2, 2012
Registry last updated
Oct 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.