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Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 Lesions

NCT02638935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1304

Last updated 2020-04-10

No results posted yet for this study

Summary

The primary aim of this study is to evaluate if VTIQ in addition to BI-RADS® categorization can improve the diagnostic accuracy with respect to detection of malignancies, in particular for BI-RADS® categories 3 and 4a. The idea of the study is to restage all patients in categories 3 and 4a according to a predefined VTIQ cut-off value of ≥ 3.5 m/s (37 kPa).

Conditions

  • Breast Neoplasms

Interventions

DEVICE

Ultrasound- Virtual Touch Tissue Imaging Quantification

Siemens Medical Solutions USA, Inc. (Mountain View, CA) has implemented Virtual Touch Tissue Imaging Quantification (VTIQ) technology on a commercially available general purpose US imaging system (trade name: Acuson S2000 or S3000). This system has received clearance under Food and Drug Administration (FDA) 510(k) number K072786 (S3000) and K130881 (VTIQ). The technology uses a set of tailored US pulses (Acoustic Radiation Force Impulse, ARFI) to induce shear waves in breast tissue due to tissue displacement. A set of standard B-mode pulses detect the perpendicular shear waves. The displacement signals can be processed using algorithms on a Virtual Touch IQ-equipped system in order to calculate the shear wave velocity.

Sponsors & Collaborators

  • Siemens Medical Solutions

    collaborator INDUSTRY

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Michael Golatta, PD Dr. med., MHBA · University of Heidelberg, Department of Gynecology, Breast Unit

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-03-31
Completion
2019-03-31
FDA Device
Yes

Countries

  • United States
  • France
  • Germany
  • Japan
  • Netherlands
  • Portugal

Study Locations

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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 NCT02638935 on ClinicalTrials.gov