Breast CancerNCT03491917
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer
An observational study of Breast Cancer, run by Fujifilm Medical Systems USA, Inc. at 1 site in United States.
Trial summary
The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study. 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?
- DBT plus S-View and FFDM alone
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2017to 15 Feb 2018
- 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: This clinical research is a retrospective, pilot, multi-reader, multi-case (MRMC) study with an enriched sample of 100 breast screening or diagnostic cases which were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects previously provided written informed consent agreeing their image data and supporting documentation could be used for future research and investigations).
Who may be able to join
- Female subjects participating in FMSU2013-004A protocol with known clinical status
Who cannot join
- Female subjects that did not have known clinical status in FMSU2013-004A
Trial locations and contacts
1 site in 1 country.
United States1 site
International HealthCare, LLC
Norwalk, Connecticut, 06851
About this study
Official title: A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pilot Study
The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.
Read the detailed description
This clinical research is a retrospective, pilot, multi-reader, multi-case (MRMC) study with an enriched sample of 100 breast screening or diagnostic cases which were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects previously provided written informed consent agreeing their image data and supporting documentation could be used for future research and investigations). Approximately 6 qualified radiologists will independently perform two reads on all (approximately 100) cases. Each reader will read each case both as a FFDM (Full Field Digital Mammography) read, and a DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) read on the ASPIRE Bellus II workstation.
- Conditions
- Breast Cancer
- Being tested
- DBT plus S-View, FFDM alone
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT plus S-ViewDevice
DBT plus S-View images
FFDM aloneDevice
FFDM alone images
| Study group | Role | What they receive |
|---|---|---|
| DBT plus S-View | Breast images utilizing DBT plus S-View Receives: Device: DBT plus S-View | |
| FFDM alone | Breast images using FFDM alone only Receives: Device: FFDM alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Per Subject Average Area Under the ROC (Receiver Operating Characteristic) Curve (AUC)
Compare per subject average area under the ROC curve (AUC) for DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) versus FFDM (Full Field Digital Mammography), based on per-subject POM (probability of malignancy) scores and requiring correct lesion localization. The primary endpoint was non-inferior per-subject average AUC. Statistician estimated AUCs for each reader in each review condition (FFDM, DBT plus S-View) based on per-subject POM scores requiring correct lesion localization. Statistician also calculated for each reader the non-parametric (trapezoidal) AUC for the FFDM read, the DBT plus S-View read, and the difference between them. These AUC's, differences between them, and the associated variance-covariance matrix were obtained using the method of DeLong, et al.
Measured: 2 visits with 4 week washout period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start3 Nov 2017
- Primary completion31 Dec 2017
- Study completion15 Feb 2018
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 crossover
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurie L. Fajardo, M.D., Principal investigator, independent contractor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491917
- Sponsor's protocol ID
- FMSU2017-002A
- Status last verified
- Jun 2020
- First submitted
- 28 Jan 2018
- Last updated
- 18 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pilot Study
- ClinicalTrials.gov ID
- NCT03491917
- Acronym / sponsor ID
- FMSU2017-002A
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 9 Apr 2018 (actual)
- 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 provide credible performance estimate information in order to conduct a subsequent pivotal reader study.
Detailed description
This clinical research is a retrospective, pilot, multi-reader, multi-case (MRMC) study with an enriched sample of 100 breast screening or diagnostic cases which were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects previously provided written informed consent agreeing their image data and supporting documentation could be used for future research and investigations). Approximately 6 qualified radiologists will independently perform two reads on all (approximately 100) cases. Each reader will read each case both as a FFDM (Full Field Digital Mammography) read, and a DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) read on the ASPIRE Bellus II workstation.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBT plus S-View | – | Device: DBT plus S-ViewBreast images utilizing DBT plus S-View |
| FFDM alone | – | Device: FFDM aloneBreast images using FFDM alone only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This clinical research is a retrospective, pilot, multi-reader, multi-case (MRMC) study with an enriched sample of 100 breast screening or diagnostic cases which were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects previously provided written informed consent agreeing their image data and supporting documentation could be used for future research and investigations).
Key inclusion criteria (1 listed)
- Female subjects participating in FMSU2013-004A protocol with known clinical status
Key exclusion criteria (1 listed)
- Female subjects that did not have known clinical status in FMSU2013-004A
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 |
|---|---|---|
| DBT plus S-ViewDBT plus S-View images | Device | DBT plus S-View |
| FFDM aloneFFDM alone images | Device | FFDM alone |
Primary outcome
Compare Per Subject Average Area Under the ROC (Receiver Operating Characteristic) Curve (AUC)
Time frame: 2 visits with 4 week washout period
Compare per subject average area under the ROC curve (AUC) for DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) versus FFDM (Full Field Digital Mammography), based on per-subject POM (probability of malignancy) scores and requiring correct lesion localization. The primary endpoint was non-inferior per-subject average AUC. Statistician estimated AUCs for each reader in each review condition (FFDM, DBT plus S-View) based on per-subject POM scores requiring correct lesion localization. Statistician also calculated for each reader the non-parametric (trapezoidal) AUC for the FFDM read, the DBT plus S-View read, and the difference between them. These AUC's, differences between them, and the associated variance-covariance matrix were obtained using the method of DeLong, et al.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- 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.
Laurie L. Fajardo, M.D. principal investigator
independent contractor
1 site 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 1 site 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 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Compare Per Subject Average Area Under the ROC (Receiver Operating Characteristic) Curve (AUC) (time frame: 2 visits with 4 week washout period). 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 18 Jun 2020.