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Completed

NCT Number: NCT01928992

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

ACR / Image Metrix

Philadelphia, Pennsylvania, 19103, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D

Device

subjects that underwent 3D mammography

2D

Device

those subjects that underwent 2D mammography

Primary outcomes

  1. Per Breast AUC

    Time frame: 1 Day

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

Secondary outcomes

  1. Subject Recall Rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fujifilm Medical Systems USA, Inc.

Industry

Registry information

Official study title

A Multi-reader, Multi-case, Controlled Clinical Trial to Evaluate the Fuji Film 3D Digital Mammography System Used in Conjunction With 2D Digital Mammography in the Detection of Breast Cancer / A Pilot Study

Acronym: 3DM

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 27, 2013
Registry last updated
Nov 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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