CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 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/NCT03501693
NCT03501693N/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 Pivotal Study

Fujifilm Medical Systems USA, Inc.·observational·Posted Apr 18, 2018·Updated Sep 21, 2023

In Brief

An observational study evaluating DBT plus S-View and FFDM Alone for Breast Cancer. Completed, enrolled 300 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 18, 2018
Enrollment StartApr 6, 2018
Primary CompletionMay 24, 2018
Study CompletionAug 31, 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