Breast CancerNCT02156258
Acquisition of Breast Mammography Images
An observational study of Breast Cancer, run by Fujifilm Medical Systems USA, Inc. at 5 sites in United States.
Trial summary
This is a case collection study of breast images using standard and new mammography technology. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- FFDM Mammography and DBT Mammography
- Type of treatment
- Medical device
- How many people
- 1,232 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2014to Jan 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of at least 200 cancer, 175 recall cases and 350 negative/benign cases will be accumulated
Who may be able to join
- 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,
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- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of North Carolina - at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Elizabeth Wende Breast Care, LLC
Rochester, New York, 14620
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Scottsdale Medical Imaging, Ltd
Scottsdale, Arizona, 85258
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- FFDM Mammography, DBT Mammography
- Keywords
- Imaging, Mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFDM MammographyDevice
Standard mammography image collection
DBT MammographyDevice
Collection of breast images using DBT mammography
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: FFDM Mammography; Device: 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 Receives: Device: FFDM Mammography; Device: DBT Mammography | |
| Screening Cases | Collection of cases who underwent routine screening mammography using FFDM Mammography and DBT Mammography Receives: Device: FFDM Mammography; Device: DBT Mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Etta D Pissano, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156258
- Sponsor's protocol ID
- FMSU2013-004A
- Status last verified
- May 2020
- First submitted
- 2 Jun 2014
- Last updated
- 20 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acquisition of Digital Mammography and Breast Images for Clinical Evaluation of FujifilmDigital Breast Tomosynthesis
- ClinicalTrials.gov ID
- NCT02156258
- Acronym / sponsor ID
- FMSU2013-004A
- Conditions
- Breast Cancer
- Keywords
- Imaging, Mammography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,232 participants (actual)
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Posted 20 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a case collection study of breast images using standard and new mammography technology.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Cases | – | Device: FFDM Mammography, Device: DBT MammographyCollection 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 |
| Recall Cases | – | Device: FFDM Mammography, Device: DBT MammographyCollection of Imaging Recall Cases (were scheduled for additional imaging due an assessment of BI-RADS 0) using FFDM Mammography and DBT Mammography |
| Screening Cases | – | Device: FFDM Mammography, Device: DBT MammographyCollection of cases who underwent routine screening mammography using FFDM Mammography and DBT Mammography |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of at least 200 cancer, 175 recall cases and 350 negative/benign cases will be accumulated
Key inclusion criteria (12 listed)
- For Screening Subjects
- Be at least 40 years of age, are
- Asymptomatic,
- Scheduled for a routine screening mammogram
- For Recall Subjects
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFDM MammographyStandard mammography image collection | Device | Diagnostic Cases, Recall Cases, Screening Cases |
| DBT MammographyCollection of breast images using DBT mammography | Device | Diagnostic Cases, Recall Cases, Screening Cases |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etta D Pissano, MD principal investigator
Medical University of South Carolina
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Fujifilm Medical Systems USA, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants for Whom Study Image Data Were Collected (time frame: 20 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.