Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program

NCT02685566 | Completed Results

• 1 other identifier: FMSU2013-004F
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation of FFDM and DBT images.

Conditions

Breast Cancer

Keywords

Mammography

Outcome Measures

Primary Outcomes (1)

• Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate

  This endpoint was evaluated qualitatively. Reported the number of readers meeting the Pass Criteria on the final FFDM plus DBT assessment case set, which requires adequate performance in cancer cases (detection rate) as well as non-cancer cases (recall rate). Per-subject BI-RADS, POM and recall scores were derived. Credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. Findings that did not match the location of a malignant lesion were ignored for cancer cases in the per-subject analyses.

  4 weeks

Secondary Outcomes (1)

• Area Under Curve (AUC) ROC (Receiver Operating Characteristic) Based on Per-subject Probability of Malignancy (POM) Scores Requiring Correct Lesion Localization.

  5 weeks

Study Arms (2)

FFDM Plus DBT

EXPERIMENTAL

Breast Images with FFDM and DBT

Device: FFDM Plus DBT

Full-Field Digital Mammography

ACTIVE COMPARATOR

Breast Images with FFDM alone

Device: FFDM

Interventions

FFDM Plus DBT DEVICE

FujiFilm Aspire Cristalle System

FFDM Plus DBT

FFDM DEVICE

FujiFilm Aspire Cristalle System

Full-Field Digital Mammography

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects participating in FMSU004A protocol with known clinical status

You may not qualify if:

• Subjects with unknown clinical status not participating in FMSU004A protocol.

Sponsors & Collaborators

• Fujifilm Medical Systems USA, Inc.: lead

Study Sites (5)

Scottsdale Medical Imaging, Limited (SMIL)

Scottsdale, Arizona, 85258, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Elizabeth Wende Breast Care, LLC (EWBC)

Rochester, New York, 14620, United States

Location

University of North Carolina - at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, 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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: February 18, 2016
• Study Start: August 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 21, 2023
• Results First Posted: June 9, 2020

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)