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

NCT02540083 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2019-02-05

Study results available
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Summary

The aim of this recruitment plan (ADAPT-Enrich) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results from biopsy specimen examination and cancer classification data from initially asymptomatic women referred for clinically indicated breast biopsy based on suspicious DBT screening breast imaging results. These data will be included in a subsequent and prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other performance measures.

Conditions

Interventions

DEVICE

DBT and FFDM

Subjects underwent FFDM breast imaging followed by DBT breast imaging

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-05-30
Completion
2017-05-30

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 NCT02540083 on ClinicalTrials.gov