Collection of FUJIFILM's 3Dimensional Mammograms

Breast Cancer Clinical Trial

— 3DM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542814
• Other study ID #: FMSU2011-003A
• Status: Completed
• Phase: Phase 3
• First received: February 27, 2012
• Last updated: October 23, 2013
• Start date: February 2012
• Est. completion date: June 2013

Study information

• Verified date: October 2013
• Source: Fujifilm Medical Systems USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• 3Dimensional Mammography
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.
• 2D FFDM
Standard of care screening mammogram.

Locations

Country	Name	City	State
United States	Emory University Healthcare	Atlanta	Georgia
United States	Elizabeth Wende Breast Care, LLC (EWBC)	Rochester	New York
United States	Scottsdale Medical Imaging, Limited (SMIL)	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Fujifilm Medical Systems USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acquire screening cases with and without breast cancer.		18-months	No