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

Phase 3
40 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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

- 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).

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Acquire screening cases with and without breast cancer.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Carl J. D'Orsi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Healthcare


United States: Food and Drug Administration

Study ID:




Start Date:

February 2012

Completion Date:

May 2013

Related Keywords:

  • Breast Cancer
  • Screening Mammogram
  • Diagnostic Mammogram
  • Benign
  • Malignant
  • BI-RADS Categories
  • Breast Neoplasms



Scottsdale Medical Imaging, Limited (SMIL) Scottsdale, Arizona  85258
Emory University Healthcare Atlanta, Georgia  30322
Elizabeth Wende Breast Care, LLC (EWBC) Rochester, New York  14620