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Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography

NCT02306265 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2019-01-29

Study results available
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Summary

The aim of this recruitment plan (ADAPT-SCR) is to collect image and other data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) from asymptomatic women undergoing screening mammography.

Conditions

Interventions

DEVICE

FFDM

2D imaging of the breast using Full-Field Digital Mammography (FFDM) device

DEVICE

DBT

3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Murray Rebner, MD · Beaumont Health

  • William Poller, MD · West Penn Allegheny Health System

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-07-07
Completion
2017-07-07

Countries

  • United States

Study Locations

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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 NCT02306265 on ClinicalTrials.gov