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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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

Other trials in United States

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 groups in NCT03491917
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.

3 Nov 201715 Feb 2018

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

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

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

Results posted to the registry on 9 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DBT Plus S-View	50	50
FFDM Alone	50	50

Primary outcome: Compare Per Subject Average Area Under the ROC (Receiver Operating Characteristic) Curve (AUC)

Time frame: 2 visits with 4 week washout period. Mean (95% Confidence Interval). Unit: Probability

Measure	DBT Plus S-View n = 100	FFDM Alone n = 100
Value	0.819 (0.719 to 0.919)	0.796 (0.700 to 0.891)

DBT Plus S-View vs FFDM Alone: p <0.01, t-test, 2 sided

Population analysed: Retrospective images used from Fujifilm protocol FMSU2013-004A. All readers read the same 100 images in their own randomized order during 2 sessions (they read half of each modality at each session which were separated by a 4 week washout period).

Adverse events

Time frame: Approximately 5 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DBT Plus S-View	0 of 100 (0%)	0 of 100 (0%)	0 of 100
FFDM Alone	0 of 100 (0%)	0 of 100 (0%)	0 of 100

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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Not yet recruitingObservational study
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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?

On the ClinicalTrials.gov record for NCT03491917.

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.