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

NACompletedINTERVENTIONAL
Enrollment

1,304

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

March 31, 2019

Study Completion Date

March 31, 2019

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.

Trial Locations (11)

17475

Universitätsmedizin Greifswald, Klinik für Frauenheilkunde und Geburtshilfe, Greifswald

33615

Franziskus Hospital, Bielefeld

35033

Universitätsklinikum Marburg, Klinik für Gynäkologie, gyn. Endokrinologie und Onkologie Senologische Diagnostik & Gynäkologischer Ultraschall, Marburg

44512

Radiology Consultants, Inc., Youngstown

69120

University of Heidelberg, Heidelberg

72076

Universitätsklinikum Tübingen, Tübingen

81377

LMU Klinikum der Universität München, München

Unknown

Institut Gustave Roussy, Service de Radiologie, Villejuif Cedex, Villejuif

Sagara Hospital, Kagoshima

GZ5223

Jeroen Bosch Hospital, 's-Hertogenbosch

3000-075

Centro Hospitalar e Universitário de Coimbra, Departamento de Radiologia, Coimbra

All Listed Sponsors
collaborator

Siemens Medical Solutions

INDUSTRY

lead

Heidelberg University

OTHER

NCT02638935 - Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 Lesions | Biotech Hunter | Biotech Hunter