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

Completed

• Conditions: Breast Cancer
• Interventions: Device: 3D; Device: 2D

• Registration Number: NCT01928992
• Lead Sponsor: Fujifilm Medical Systems USA, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-27
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3D	3D	Subjects that undergo 3D mammography
2D	2D	Subjects that undergo 2D mammography

Primary Outcome Measures

Name	Time	Method
Per Breast AUC	1 Day	Breast AUC performance metrics to determine if 3D has improved breast cancer detection rate as compared to 2D.

Secondary Outcome Measures

Name	Time	Method
Subject Recall Rate	1 Day	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

Trial Locations

Locations (1)

ACR / Image Metrix; 🇺🇸 Philadelphia, Pennsylvania, United States