Breast CancerNCT02685566
Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program
A study testing FFDM Plus DBT and FFDM in people with Breast Cancer, run by Fujifilm Medical Systems USA, Inc. at 5 sites in United States.
Trial summary
The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation of FFDM and DBT images. 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 Plus DBT and FFDM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2015to Oct 2015
- Phase
- Interventional
- 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
Who may be able to join
- Female subjects participating in FMSU004A protocol with known clinical status
Who cannot join
- Subjects with unknown clinical status not participating in FMSU004A protocol.
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 and Clinics
Iowa City, Iowa, 52242
Elizabeth Wende Breast Care, LLC (EWBC)
Rochester, New York, 14620
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Scottsdale Medical Imaging, Limited (SMIL)
Scottsdale, Arizona, 85258
About this study
Official title: A Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Adequacy of the Fujifilm Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) Reader Training Program - A Pilot Study
The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation of FFDM and DBT images.
Read the detailed description
For this reader study, radiologists review images obtained via protocol FMSU2013-004A. They review both FFDM alone and FFDM + DBT images, and provide a BI-RADS and POM for each. The radiologists performance metrics for the following modalities will be evaluated: FFDM and FFDM + DBT.
- Conditions
- Breast Cancer
- Being tested
- FFDM Plus DBT, FFDM
- Keywords
- 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 Plus DBTDevice
FujiFilm Aspire Cristalle System
FFDMDevice
FujiFilm Aspire Cristalle System
| Study group | Role | What they receive |
|---|---|---|
| FFDM Plus DBT | Experimental | Breast Images with FFDM and DBT Receives: Device: FFDM Plus DBT |
| Full-Field Digital Mammography | Active comparator | Breast Images with FFDM alone Receives: Device: FFDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate
This endpoint was evaluated qualitatively. Reported the number of readers meeting the Pass Criteria on the final FFDM plus DBT assessment case set, which requires adequate performance in cancer cases (detection rate) as well as non-cancer cases (recall rate). Per-subject BI-RADS, POM and recall scores were derived. Credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. Findings that did not match the location of a malignant lesion were ignored for cancer cases in the per-subject analyses.
Measured: 4 weeks
Secondary outcomes (1)
Area Under Curve (AUC) ROC (Receiver Operating Characteristic) Based on Per-subject Probability of Malignancy (POM) Scores Requiring Correct Lesion Localization.
The magnitude and direction of differences between performance metrics for the two modalities, and variance components and correlations that would influence sample size and case mix for the pivotal reader study (FMSU2013-004G) comparing performance metrics between the two modalities, obtained using established methods for analysis of MRMC (multi-reader, multi-case) studies. The statistician estimated AUC's for each reader in each review condition based on per-subject POM scores requiring correct lesion localization. Statistician performed MRMC comparison of AUC's between reading conditions using the MRMC analysis of variance (ANOVA) method.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startAug 2015
- Primary completionAug 2015
- Study completionOct 2015
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert M Uzenoff, Study director, Fujifilm Medical Systems USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685566
- Sponsor's protocol ID
- FMSU2013-004F
- Status last verified
- Sep 2023
- First submitted
- 17 Aug 2015
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Adequacy of the Fujifilm Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) Reader Training Program - A Pilot Study
- ClinicalTrials.gov ID
- NCT02685566
- Acronym / sponsor ID
- FMSU2013-004F
- Conditions
- Breast Cancer
- Keywords
- Mammography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Posted 9 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation of FFDM and DBT images.
Detailed description
For this reader study, radiologists review images obtained via protocol FMSU2013-004A. They review both FFDM alone and FFDM + DBT images, and provide a BI-RADS and POM for each. The radiologists performance metrics for the following modalities will be evaluated: FFDM and FFDM + DBT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFDM Plus DBT | Experimental | Device: FFDM Plus DBTBreast Images with FFDM and DBT |
| Full-Field Digital Mammography | Active comparator | Device: FFDMBreast Images with FFDM alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female subjects participating in FMSU004A protocol with known clinical status
Key exclusion criteria (1 listed)
- Subjects with unknown clinical status not participating in FMSU004A protocol.
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 Plus DBTFujiFilm Aspire Cristalle System | Device | FFDM Plus DBT |
| FFDMFujiFilm Aspire Cristalle System | Device | Full-Field Digital Mammography |
Primary outcome
Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate
Time frame: 4 weeks
This endpoint was evaluated qualitatively. Reported the number of readers meeting the Pass Criteria on the final FFDM plus DBT assessment case set, which requires adequate performance in cancer cases (detection rate) as well as non-cancer cases (recall rate). Per-subject BI-RADS, POM and recall scores were derived. Credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. Findings that did not match the location of a malignant lesion were ignored for cancer cases in the per-subject analyses.
1 secondary outcome
Area Under Curve (AUC) ROC (Receiver Operating Characteristic) Based on Per-subject Probability of Malignancy (POM) Scores Requiring Correct Lesion Localization.
Time frame: 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Robert M Uzenoff study director
Fujifilm Medical Systems USA, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFDM Plus DBT and FFDM in people with 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 1 inclusion and 1 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 21 Sep 2023. 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 9 Jun 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?
Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate (time frame: 4 weeks). 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 21 Sep 2023.