Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02692209 · ClinicalTrials.gov registry record
A Multi-Reader Multi-Case Pivotal Trial
A clinical trial of Breast Cancer, sponsored by Fujifilm Medical Systems USA.
- Completed
- Registry status
- 298
- Enrollment target
- 5
- Study locations
NCT02692209: Completed study of Breast Cancer, sponsored by Fujifilm Medical Systems USA.
NCT02692209 is a study of Breast Cancer that has completed, run by Fujifilm Medical Systems USA. The registered enrollment target is 298 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02692209, a study of Breast Cancer, has completed, sponsored by Fujifilm Medical Systems USA.
- COMPLETED
- Registry status
- 298 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
The study will be considered to have successfully demonstrated safety and effectiveness of the Fujifilm Aspire Cristalle: FFDM +DBT system if the per-subject average AUC for FFDM+DBT is statistically significantly superior to the average AUC for FFDM alone at the alpha = 0.05 significance level. Per-subject BI-RADS, POM and recall scores requiring correct lesion localization were derived. The general principle is that even at the subject level, credit was only given for identifying a subject wit
Conditions Studied
Interventions
- DEVICE FFDM Plus DBT
- DEVICE FFDM Alone
Study Locations (5)
Arizona
- Scottsdale Medical Imaging, Ltd - Scottsdale
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
New York
- Elizabeth Wende Breast Care, LLC (EWBC) - Rochester
North Carolina
- University of North Carolina - at Chapel Hill - Chapel Hill
Texas
- University of Texas Health Science Center at San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-01 |
What the finished NCT02692209 record still lists
NCT02692209 is an observational study that tracks outcomes without assigning an intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which FFDM Plus DBT is the first listed.
NCT02692209 lists 5 locations in 5 states (Arizona, Iowa, New York).
Frequently Asked Questions
What is clinical trial NCT02692209 about?
NCT02692209 is a clinical study titled "A Multi-Reader Multi-Case Pivotal Trial". 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.
What is the current status of trial NCT02692209?
This trial is currently completed. The enrollment target is 298 participants. The study started on 2015-12. Estimated completion is 2016-01.
What conditions does trial NCT02692209 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT02692209?
The interventions under investigation include: FFDM Plus DBT (DEVICE), FFDM Alone (DEVICE).
Who is sponsoring clinical trial NCT02692209?
This trial is sponsored by Fujifilm Medical Systems USA, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02692209 being conducted?
This trial has 5 study locations across Arizona, Iowa, New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02692209's enrollment target sits among peer trials
298 289th of 1224 higher than 936 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Genetic Analysis
RECRUITING
-
Surviving Daily Life
RECRUITING
-
Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring
RECRUITING
-
UNC Pleural Fluid Registry
RECRUITING
-
Harnessing Analysis RNA Expression and Molecular Subtype to Optimize Novel TherapY MBCA
RECRUITING · NA
-
Post-operative Radiotherapy Omission in Selected Patients With Early Breast Cancer Trial International VErsion (PROSPECTIVE)
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06305624 · 298 participants · NA
Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease
- NCT06754215 · 298 participants · NA
Smoking Cessation Intervention Development for Homeless Youth
- NCT06780111 · 298 participants · Phase 1
Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
- NCT07209358 · 298 participants · NA
EDX110 Randomized Control Trial for Treatment of DFUs
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia