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Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone

NCT02511730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-09-21

Study results available
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Summary

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

Conditions

Interventions

DEVICE

FFDM Plus DBT

FujiFilm Aspire Cristalle System

DEVICE

FFDM

FujiFilm Aspire Cristalle System

Sponsors & Collaborators

  • Fujifilm Medical Systems USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert M Uzenoff · Fujifilm Medical Systems USA, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-06-30
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02511730 on ClinicalTrials.gov