CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 298 enrolled
Drug / intervention
FFDM Plus DBT +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/NCT02692209
NCT02692209N/ACompleted
CompareCT.gov

A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm FFDM Plus DBT Versus FFDM Alone in the Detection of Breast Cancer

Fujifilm Medical Systems USA, Inc.·observational·Posted Feb 25, 2016·Updated Jul 7, 2020

In Brief

An observational study evaluating FFDM Plus DBT and FFDM Alone for Breast Cancer. Completed, enrolled 298 participants across 5 sites.

Detailed Summary

The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.

Study Details

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

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 25, 2016
Enrollment StartDec 1, 2015
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 10.4 years ago

Interventions

FFDM Plus DBTdevice

FFDM + DBT Images FujiFilm Aspire Cristalle System

FFDM Alonedevice

FFDM Alone Images