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

Completed

• Conditions: Breast Cancer
• Interventions: Device: DBT plus S-View; Device: FFDM alone

• Registration Number: NCT03491917
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-11-03
• Primary Completion: 2017-12-31
• Study First Submitted: 2018-01-28
• Study Completion: 2018-02-15
• Study First Submitted QC: 2018-04-02
• Study First Posted: 2018-04-09
• Results First Submitted: 2020-05-12
• Results First Submitted QC: 2020-05-28
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-08
• Results First Posted: 2020-06-09
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DBT plus S-View	DBT plus S-View	Breast images utilizing DBT plus S-View
FFDM alone	FFDM alone	Breast images using FFDM alone only

Primary Outcome Measures

Name	Time	Method
Compare Per Subject Average Area Under the ROC (Receiver Operating Characteristic) Curve (AUC)	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.

Trial Locations

Locations (1)

International HealthCare, LLC; 🇺🇸 Norwalk, Connecticut, United States