CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
DBT plus S-View +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03491917
NCT03491917N/ACompleted

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

Fujifilm Medical Systems USA, Inc.·observational·Posted Apr 9, 2018·Updated Jun 18, 2020

In Brief

An observational study evaluating DBT plus S-View and FFDM alone for Breast Cancer. Completed, enrolled 100 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 9, 2018
Enrollment StartNov 3, 2017
Primary CompletionDec 31, 2017
Study CompletionFeb 15, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.2 years ago

Interventions

DBT plus S-Viewdevice

DBT plus S-View images

FFDM alonedevice

FFDM alone images