CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,304 enrolled
Drug / intervention
Ultrasound- Virtual Touch Tissue Imaging Quantificationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02638935
NCT02638935N/ACompleted
CompareCT.gov

Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 Lesions: Can Patient Selection for Biopsy be Improved? - A Confirmatory Multi-Center-Study

Heidelberg University·interventional·Posted Dec 23, 2015·Updated Apr 10, 2020

In Brief

A clinical study evaluating Ultrasound- Virtual Touch Tissue Imaging Quantification for Breast Neoplasms. Completed, enrolled 1,304 participants across 11 sites in 6 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesFrance, Germany, Japan, Netherlands, Portugal, United States
CollaboratorsSiemens Medical Solutions

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 23, 2015
Enrollment StartFeb 1, 2016
Primary CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.5 years ago

Interventions

Ultrasound- Virtual Touch Tissue Imaging Quantificationdevice

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.