Acquisition of Breast Mammography Images

May 8, 2020 updated by: Fujifilm Medical Systems USA, Inc.

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

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

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1232

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Scottsdale Medical Imaging, Ltd
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics
    • New York
      • Rochester, New York, United States, 14620
        • Elizabeth Wende Breast Care, LLC
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina - at Chapel Hill
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

A total of at least 200 cancer, 175 recall cases and 350 negative/benign cases will be accumulated

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diagnostic Cases
Collection of cases that were scheduled for biopsy (BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography
Standard mammography image collection
Collection of breast images using DBT mammography
Recall Cases
Collection of Imaging Recall Cases (were scheduled for additional imaging due an assessment of BI-RADS 0) using FFDM Mammography and DBT Mammography
Standard mammography image collection
Collection of breast images using DBT mammography
Screening Cases
Collection of cases who underwent routine screening mammography using FFDM Mammography and DBT Mammography
Standard mammography image collection
Collection of breast images using DBT mammography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants for Whom Study Image Data Were Collected
Time Frame: 20 Months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Etta D Pissano, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 2, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (Estimate)

June 5, 2014

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 8, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FMSU2013-004A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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