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

NCT03501693 | Completed Results FDA Device

• 1 other identifier: FMSU2017-002B
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the pivotal reader study is to assess the comparative accuracy of Fujifilm DBT plus S-View versus FFDM in the detection of breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Compare Per Subject AUC: DBT Plus S-View Versus FFDM

  Average of each radiologist reader's ROC (receiving operating characteristic curve) based on per-subject POM (probability of malignancy) scores requiring correct lesion localization. A ROC curve is a plot of Sensitivity versus 1-Specificity and is a summary of diagnostic performance of a device or clinician. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject.

  4 weeks

Secondary Outcomes (3)

• Compare Per-subject Average Recall Rate for All Non-cancer Cases for DBT Plus S-View Versus FFDM

  4 weeks

• Compare Per-subject Average Recall Rate for DBT Plus S-View Versus FFDM for All Cancer Cases

  4 weeks

• Compare Per-subject Average Sensitivity for DBT Plus S-View Versus FFDM

  Four weeks

Study Arms (2)

DBT plus S-View

Breast images utilizing DBT plus S-View

Device: DBT plus S-View

FFDM alone

FFDM alone images

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 is a reader study utilizing retrospectively collected breast images acquired under Fujifilm protocol FMSU2013-004A.

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

• Robert M Uzenoff

  Fujifilm Medical Systems USA, Inc.

  STUDY DIRECTOR

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: April 2, 2018
• First Posted: April 18, 2018
• Study Start: April 6, 2018
• Primary Completion: May 24, 2018
• Study Completion: August 31, 2018
• Last Updated: September 21, 2023
• Results First Posted: June 4, 2020

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)