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Diagnostic Performance of an Automated Breast Ultrasound System (ABUS)

NCT02661204 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2022-11-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the diagnostic performance of a new ABUS system among 4 different population:

Population A: women undergoing screening for familial or genetic predisposition for breast cancer.

Population B: women with newly diagnosed breast cancer. ABUS performance will be compared to breast MRI in the pre-operative assessment of breast cancer extent.

Population C: women with BI-RADS 3 or 4 lesions in a routine breast imaging examination. ABUS will be evaluate as a problem-solving tool.

Population D: women undergoing breast MRI for the assessment of breast implants integrity. ABUS performance will be compared to breast MRI.

Conditions

Interventions

DEVICE

Automated breast ultrasound examination (ABUS)

Automated breast ultrasound examination

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Andreas Boss, MD · University Hospital Zurich, Institute of Diagnostic and Interventional Radiology, University Hospital Zurich

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2023-05-31
Completion
2023-10-31

Countries

  • Switzerland

Study Locations

More Related Trials

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 NCT02661204 on ClinicalTrials.gov