Acquisition of Breast Mammography Images

Breast Cancer Clinical Trial

Official title:

Acquisition of Digital Mammography and Breast Images for Clinical Evaluation of FujifilmDigital Breast Tomosynthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156258
• Other study ID #: FMSU2013-004A
• Status: Completed
• Start date: June 2014
• Est. completion date: January 2017

Study information

• Verified date: May 2020
• Source: Fujifilm Medical Systems USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a case collection study of breast images using standard and new mammography technology.

Description:

This image acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. This study will create a library of image data that will be used for future projects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1232
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

For Screening Subjects

• Be at least 40 years of age, are

• Asymptomatic,

• Scheduled for a routine screening mammogram

For Recall Subjects

• Be at least 18 years of age,

• Received a BIRADS 0 within the last 60 days

• Are recalled for additional imaging

For Diagnostic Subjects

• Be at least 18 years of age,

• Scheduled for a biopsy due to an assessment of Breast Imaging and Reporting Data (BI-RADS®) 4 or 5 after diagnostic work-up of a suspicious screening or clinical finding within the last 60 days.

• Understand requirements and willing to participate in study

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 within the last one year.

• Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate digital mammography and/or breast tomosynthesis examinations.

• A woman who has had a mammogram performed for the purpose of therapy portal planning within the last year.

• Cannot, for any known reason, undergo follow-up digital mammography and/or breast tomosynthesis examinations (where clinically indicated) at the participating institution.

• Is an inmate (see US Code of Federal Regulations 45CFR46.306).

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• FFDM Mammography
Standard mammography image collection
• DBT Mammography
Collection of breast images using DBT mammography

Locations

Country	Name	City	State
United States	University of North Carolina - at Chapel Hill	Chapel Hill	North Carolina
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	Elizabeth Wende Breast Care, LLC	Rochester	New York
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Scottsdale Medical Imaging, Ltd	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	Number of Participants for Whom Study Image Data Were Collected	This study created a library of image data to be used in future projects, future product development and regulatory submissions. There was no analysis conducted aside from confirmation of complete images and collected data , as this was merely a collection of images to be used in future reader studies. Sites were provided a target distribution of diagnostic, recall and screening cases to obtain.	20 Months