Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection in 3D Versus 2D Digital Mammography

N/ACompletedNCT01928992

Fujifilm Medical Systems USA, Inc.100 enrolled

Overview

The purpose of this pilot study is to provide credible performance estimate information in order to properly plan, design, and power a larger clinical study.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Breast Cancer

Interventions

3DDEVICE

subjects that underwent 3D mammography

2DDEVICE

those subjects that underwent 2D mammography

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female subjects participating in prior FMSU protocol with known clinical status Exclusion Criteria: * Subjects with unkown clinical status * Subjects not truthed in prior FMSU study

Locations (1)

ACR / Image Metrix

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Per Breast AUC

Breast AUC performance metrics to determine if 3D has improved breast cancer detection rate as compared to 2D.

Time frame: 1 Day

Secondary Outcomes

Subject Recall Rate

For Cancer and Non-Cancer Cases to determine if 3D can reduce the need for follow-up mammography and/or improve time to determination of need for a biopsy

Time frame: 1 Day

Data from ClinicalTrials.gov

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