Clinical trial NCT01542814: Collection of FUJIFILM's 3Dimensional Mammograms
Official title: Acquisition of Mammography Images for Clinical Evaluation of FUJIFILM 3Dimensional Mammography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Screening Mammogram
Diagnostic Mammogram
Benign
Malignant
BI-RADS Categories
Lead sponsor: Fujifilm Medical Systems USA, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-02
Enrollment: 600
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects who are appearing for a routine screening examination or have been referred for further diagnostic evaluation after a screening examination (within 45 days) or have a 4-view mammogram (within 45 days) due to clinical concerns will be eligible to participate in the study.

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

Eligibility criteria: 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).

Primary outcomes:
measure: Acquire screening cases with and without breast cancer.
timeFrame: 18-months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging, Limited (SMIL)
state: Arizona
city: Atlanta
country: United States
facility: Emory University Healthcare
state: Georgia
city: Rochester
country: United States
facility: Elizabeth Wende Breast Care, LLC (EWBC)
state: New York
Study officials:
affiliation: Emory University Healthcare
name: Carl J. D'Orsi, MD
role: PRINCIPAL_INVESTIGATOR
References: