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Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis

NCT03616457 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2018-10-26

No results posted yet for this study

Summary

The purpose of this study is to assess whether the Invenia™ Automated Breast Ultrasound (ABUS) device, as an adjunct to Digital Breast Tomosynthesis (DBT), improves breast cancer detection in women with dense breasts. The study aims to collect information about cancer detection, treatment, and outcomes based on individual and combined technologies in patients who receive ABUS exams in addition to DBT. The results of this study are intended to be used to extend understanding of ABUS as an adjunct in DBT screening in patients with dense breasts.

Conditions

Interventions

DEVICE

Automated Breast Ultrasound (ABUS)

Participants will undergo imaging with ABUS.

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Georgia Spear · Endeavor Health

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2021-08-31
Completion
2021-08-31
FDA Device
Yes

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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 NCT03616457 on ClinicalTrials.gov