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

NCT03491917 | Completed Results FDA Device

• 1 other identifier: FMSU2017-002A
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  2 visits with 4 week washout period

Study Arms (2)

DBT plus S-View

Breast images utilizing DBT plus S-View

Device: DBT plus S-View

FFDM alone

Breast images using FFDM alone only

Device: FFDM alone

Interventions

DBT plus S-View DEVICE

DBT plus S-View images

DBT plus S-View

FFDM alone DEVICE

FFDM alone images

FFDM alone

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fujifilm Medical Systems USA, Inc.: lead

Study Sites (1)

International HealthCare, LLC

Norwalk, Connecticut, 06851, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Randy Vader
• Organization: Fujifilm Medical Systems USA, Inc.

randy.vader@fujifilm.com

360-356-6821

Study Officials

• Laurie L. Fajardo, M.D.

  independent contractor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2018
• First Posted: April 9, 2018
• Study Start: November 3, 2017
• Primary Completion: December 31, 2017
• Study Completion: February 15, 2018
• Last Updated: June 18, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)