- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02156258
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
Intervention / Treatment
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
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Arizona
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Scottsdale, Arizona, United States, 85258
- Scottsdale Medical Imaging, Ltd
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-
Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals & Clinics
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New York
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Rochester, New York, United States, 14620
- Elizabeth Wende Breast Care, LLC
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina - at Chapel Hill
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Texas
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio
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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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