Breast CancerNCT03586583
Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing
An observational study of Breast Cancer, run by Fujifilm Medical Systems USA, Inc. at 1 site in United States.
Trial summary
The purpose of the feature comparison study is to evaluate general mammographic features in images of the same breast when reconstructed with modified (ISR and DVIIm) processing as compared to the original processing (FBP with EDR and MFP). 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?
- FBP and ISR
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2018to 19 Nov 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: 600
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 Feature Comparison Study to Evaluate the Modified Processing of Fujifilm's ASPIRE Cristalle With Digital Breast Tomosynthesis Option as Compared to the Original Processing
The purpose of the feature comparison study is to evaluate general mammographic features in images of the same breast when reconstructed with modified (ISR and DVIIm) processing as compared to the original processing (FBP with EDR and MFP).
Read the detailed description
This clinical research is a retrospective, feature comparison reader study with an enriched sample of 600 (100 per radiologist) 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).
Six MQSA-qualified and board-certified mammographers representing various experience levels, will be shown DBT images of a breast with the modified processing side-by-side the same breast with the original processing on the ASPIRE Bellus II workstation.. One breast per subject (two views per breast; CC and MLO) will be evaluated by the readers. Readers will be blinded to the image reconstruction and presentation processing methods. Each reader will be given a different sample of cases to review. Approximately 600 total cases (100 cases per reader) will compose the sample. The order of the subjects and location (left or right review workstation high resolution monitor) of the images with modified processing will be randomized for each reader.
The primary objective is the readers' assessment for each of the 7 general mammographic features. The null hypothesis is that the pooled proportion of cases judged as non-inferior with modified image processing is <0.50, versus the alternative hypothesis that the pooled proportion is >0.50. If the 95% CI does not contain values <0.50, then the null hypothesis will be rejected. These hypotheses will be evaluated for each of the 7 general mammographic features. If all 7 null hypotheses are rejected, then it will be concluded that the modified imaging features are non-inferior to the original imaging
- Conditions
- Breast Cancer
- Being tested
- FBP, ISR
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FBPDevice
Old processing
ISRDevice
New processing
| Study group | Role | What they receive |
|---|---|---|
| FBP (old processing) | Filtered back projection; old processing. Receives: Device: FBP | |
| ISR (new processing) | Iterative super resolution; new processing. Receives: Device: ISR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of ISR (Modified Processing) to FBP (Original Processing)
For each reader, the cases judged as non-inferior with modified processing will be calculated for each feature and each view. Non-inferiority will be defined as a score of equivalence between modified and original or a score indicating the modified image processing is superior. Readers compared several general mammographic features using the following 5-point scale:
negative 2 (left image much superior) negative 1 (left image somewhat superior) 0 (left and right images are equivalent) positive 1 (right image somewhat superior) positive 2 (right image much superior)
Measured: 1 day reading session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start30 Jun 2018
- Primary completion30 Jun 2018
- Study completion19 Nov 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International HealthCare, LLC
- Responsible party
- Sponsor
- Investigators
- Susan Crennan, Study director, Fujifilm Medical Systems USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586583
- Sponsor's protocol ID
- FMSU2017-003
- Status last verified
- Sep 2023
- First submitted
- 2 Jul 2018
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feature Comparison Study to Evaluate the Modified Processing of Fujifilm's ASPIRE Cristalle With Digital Breast Tomosynthesis Option as Compared to the Original Processing
- ClinicalTrials.gov ID
- NCT03586583
- Acronym / sponsor ID
- FMSU2017-003
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.Industry (pharma, biotech, devices)
- Collaborators
- International HealthCare, LLC
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 19 Nov 2018 (actual)
- First posted
- 13 Jul 2018 (actual)
- 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.
The purpose of the feature comparison study is to evaluate general mammographic features in images of the same breast when reconstructed with modified (ISR and DVIIm) processing as compared to the original processing (FBP with EDR and MFP).
Detailed description
This clinical research is a retrospective, feature comparison reader study with an enriched sample of 600 (100 per radiologist) 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).
Six MQSA-qualified and board-certified mammographers representing various experience levels, will be shown DBT images of a breast with the modified processing side-by-side the same breast with the original processing on the ASPIRE Bellus II workstation.. One breast per subject (two views per breast; CC and MLO) will be evaluated by the readers. Readers will be blinded to the image reconstruction and presentation processing methods. Each reader will be given a different sample of cases to review. Approximately 600 total cases (100 cases per reader) will compose the sample. The order of the subjects and location (left or right review workstation high resolution monitor) of the images with modified processing will be randomized for each reader.
The primary objective is the readers' assessment for each of the 7 general mammographic features. The null hypothesis is that the pooled proportion of cases judged as non-inferior with modified image processing is <0.50, versus the alternative hypothesis that the pooled proportion is >0.50. If the 95% CI does not contain values <0.50, then the null hypothesis will be rejected. These hypotheses will be evaluated for each of the 7 general mammographic features. If all 7 null hypotheses are rejected, then it will be concluded that the modified imaging features are non-inferior to the original imaging
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FBP (old processing) | – | Device: FBPFiltered back projection; old processing. |
| ISR (new processing) | – | Device: ISRIterative super resolution; new processing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 600
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 |
|---|---|---|
| FBPOld processing | Device | FBP (old processing) |
| ISRNew processing | Device | ISR (new processing) |
Primary outcome
Comparison of ISR (Modified Processing) to FBP (Original Processing)
Time frame: 1 day reading session
For each reader, the cases judged as non-inferior with modified processing will be calculated for each feature and each view. Non-inferiority will be defined as a score of equivalence between modified and original or a score indicating the modified image processing is superior. Readers compared several general mammographic features using the following 5-point scale: negative 2 (left image much superior) negative 1 (left image somewhat superior) 0 (left and right images are equivalent) positive 1 (right image somewhat superior) positive 2 (right image much superior)
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.
Susan Crennan study director
Fujifilm Medical Systems USA, Inc.
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 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 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 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?
Comparison of ISR (Modified Processing) to FBP (Original Processing) (time frame: 1 day reading session). 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; AzTrials last refreshed its copy on 28 Oct 2026.