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Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03491917
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : April 12, 2018
Information provided by (Responsible Party):
Fujifilm Medical Systems USA, Inc.

Brief Summary:
The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: DBT plus S-View Device: FFDM alone Not Applicable

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 read, and a DBT plus S-View read on the ASPIRE Bellus II workstation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : November 3, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : February 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: DBT plus S-View
Breast images utilizing DBT plus S-View
Device: DBT plus S-View
DBT plus S-View images

Active Comparator: FFDM alone
Breast images using FFDM alone only
Device: FFDM alone
FFDM alone images

Primary Outcome Measures :
  1. Non-inferior per subject AUC [ Time Frame: 2 visits with 4 week washout period ]
    Non-inferior pers subject AUC: DBT plus S-View versus FFDM

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Female subjects participating in FMSU2013-004A protocol with known clinical status

Exclusion Criteria:

  • Female subjects that did not have known clinical status in FMSU2013-004A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03491917

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United States, Connecticut
International HealthCare, LLC
Norwalk, Connecticut, United States, 06851
Sponsors and Collaborators
Fujifilm Medical Systems USA, Inc.
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Principal Investigator: Laurie L. Fajardo, M.D. independent contractor

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Responsible Party: Fujifilm Medical Systems USA, Inc. Identifier: NCT03491917    
Other Study ID Numbers: FMSU2017-002A
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases