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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03491917
• Other study ID #: FMSU2017-002A
• Status: Completed
• Start date: November 3, 2017
• Est. completion date: February 15, 2018

Study information

• Verified date: June 2020
• Source: Fujifilm Medical Systems USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 15, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• DBT plus S-View
DBT plus S-View images
• FFDM alone
FFDM alone images

Locations

Country	Name	City	State
United States	International HealthCare, LLC	Norwalk	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Fujifilm Medical Systems USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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