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

NCT02638935 | Completed DMC FDA Device

• 1 other identifier: VTIQ
• Study Type: interventional
• Target: 1,304
• Locations: 6 countries
• Sites: 11

Brief 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

Keywords

Virtual Touch Tissue Imaging; VTIQ; Elastography; Breast Cancer; BI-RADS; Differentiation of breast lesions; Breast Lesion

Outcome Measures

Primary Outcomes (3)

• Standard chi-square test at a two-sided significance level of 5% to test the diagnostic accuracy of Virtual Touch Tissue Imaging Quantification (VTIQ) in the differentiation of BI-RADS® 3 and 4a lesions

  Hierarchical testing of the main statistical hypotheses H0\_1, H0\_2, H0\_3 (test for H0\_1 defines a gatekeeper) to evaluate the diagnostic accuracy of VTIQ in the differentiation of BI-RADS® 3 and 4a lesions: H0\_1: The proportion of malignancies for group A (BI-RADS 4a, VTIQ ≥ cut-off) is less or equal to the proportion of malignancies for group B (BI-RADS 4a, VTIQ \< cut-off). versus H1\_1: The proportion of malignancies for group A is higher than the proportion of malignancies for group B.

  2 years

• Standard Binomial-test according to Bonferroni-Holm to test the null hypothesis H0_2

  H0\_2: The proportion of malignancies for group B (BI-RADS 4a, VTIQ \< cut-off) is larger than or equal to 2%. versus H1\_2: The proportion of malignancies for group B is smaller than 2%.

  2 years

• Standard Binomial-test according to Bonferroni-Holm to test the null hypothesis H0_3

  H0\_3: The proportion of malignancies for group D (BI-RADS 3, VTIQ \< cut-off) is larger than or equal to 2%. versus H1\_3: The proportion of malignancies for group D is smaller than 2%.

  2 years

Secondary Outcomes (20)

• Corresponding chi-square tests for descriptive analysis of Virtual Touch Tissue Imaging Quantification (VTIQ) in the assessment of BI-RADS® 3, 4b, 4c lesions

  2 years

• BI-RADS® vs. BI-RADS® + Virtual Touch Tissue Imaging Quantification (VTIQ)

  2 years

• Corresponding chi-square tests for descriptive analysis of the strain ratio in the differentiation of BI-RADS® 3, 4a, 4b or 4c lesions

  2 years

• Robust regression models to test the INTRA-RATER reliability for the original continuous scale

  2 years

• Cohens's Kappa to test the INTRA-RATER reliability for the dichotomized values

  2 years

Study Arms (4)

BI-RADS 3

OTHER

Intervention: Ultrasound- Virtual Touch Tissue Imaging Quantification

Device: Ultrasound- Virtual Touch Tissue Imaging Quantification

BI-RADS 4a

OTHER

Intervention: Ultrasound- Virtual Touch Tissue Imaging Quantification

Device: Ultrasound- Virtual Touch Tissue Imaging Quantification

BI-RADS 4b

OTHER

Intervention: Ultrasound- Virtual Touch Tissue Imaging Quantification

Device: Ultrasound- Virtual Touch Tissue Imaging Quantification

BI-RADS 4c

OTHER

Intervention: Ultrasound- Virtual Touch Tissue Imaging Quantification

Device: Ultrasound- Virtual Touch Tissue Imaging Quantification

Interventions

Ultrasound- Virtual Touch Tissue Imaging Quantification DEVICE

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.

Also known as: Elasticity Imaging, VTIQ, Elastography, Ultrasound, ARFI

BI-RADS 3; BI-RADS 4a; BI-RADS 4b; BI-RADS 4c

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Age ≥18 years
• Patients with a lesion ≥ 0.5 cm in largest diameter size, initially scored BI-RADS® 3, 4a, 4b or 4c in B-mode ultrasound
• Informed consent about histological examination (core cut biopsy (CCB), vacuum-assisted biopsy (VAB), fine needle aspiration (FNA) or surgery) has already been given in the course of clinical routine
• Signed informed consent of study participation

You may not qualify if:

• Pregnant or lactating women
• Women with breast implants on the same side as the lesion
• Women that underwent local radiation or chemotherapy within the last 12 months
• Women with history of breast cancer or breast surgery in the same quadrant
• Lesions in or close to scar tissue (\< 1cm)
• Skin lesions or lesions that have been biopsied previously
• Lesion larger than 4 cm in the longest dimension
• No lesion should be included when more than 50% of the lesion is further down than 4 cm beneath the skin level.

Sponsors & Collaborators

• Heidelberg University: lead
• Siemens Medical Solutions: collaborator

Study Sites (11)

Radiology Consultants, Inc.

Youngstown, Ohio, 44512, United States

Location

Institut Gustave Roussy, Service de Radiologie, Villejuif Cedex

Villejuif, France

Location

Franziskus Hospital

Bielefeld, 33615, Germany

Location

Universitätsmedizin Greifswald, Klinik für Frauenheilkunde und Geburtshilfe

Greifswald, 17475, Germany

Location

University of Heidelberg

Heidelberg, 69120, Germany

Location

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

Marburg, 35033, Germany

Location

LMU Klinikum der Universität München

München, 81377, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Sagara Hospital

Kagoshima, Matsubaracho, Kagoshima-shi, Japan

Location

Jeroen Bosch Hospital

's-Hertogenbosch, GZ5223, Netherlands

Location

Centro Hospitalar e Universitário de Coimbra, Departamento de Radiologia

Coimbra, 3000-075, Portugal

Location

Related Publications (13)

• Barr RG, Zhang Z. Shear-wave elastography of the breast: value of a quality measure and comparison with strain elastography. Radiology. 2015 Apr;275(1):45-53. doi: 10.1148/radiol.14132404. Epub 2014 Nov 24.

  PMID: 25426770 BACKGROUND

• Barr RG, Zhang Z. Effects of precompression on elasticity imaging of the breast: development of a clinically useful semiquantitative method of precompression assessment. J Ultrasound Med. 2012 Jun;31(6):895-902. doi: 10.7863/jum.2012.31.6.895.

  PMID: 22644686 BACKGROUND

• Golatta M, Schweitzer-Martin M, Harcos A, Schott S, Junkermann H, Rauch G, Sohn C, Heil J. Normal breast tissue stiffness measured by a new ultrasound technique: virtual touch tissue imaging quantification (VTIQ). Eur J Radiol. 2013 Nov;82(11):e676-9. doi: 10.1016/j.ejrad.2013.06.029. Epub 2013 Aug 8.

  PMID: 23932637 BACKGROUND

• Golatta M, Schweitzer-Martin M, Harcos A, Schott S, Gomez C, Stieber A, Rauch G, Domschke C, Rom J, Schutz F, Sohn C, Heil J. Evaluation of virtual touch tissue imaging quantification, a new shear wave velocity imaging method, for breast lesion assessment by ultrasound. Biomed Res Int. 2014;2014:960262. doi: 10.1155/2014/960262. Epub 2014 Mar 31.

  PMID: 24800257 BACKGROUND

• Tozaki M, Saito M, Benson J, Fan L, Isobe S. Shear wave velocity measurements for differential diagnosis of solid breast masses: a comparison between virtual touch quantification and virtual touch IQ. Ultrasound Med Biol. 2013 Dec;39(12):2233-45. doi: 10.1016/j.ultrasmedbio.2013.07.012. Epub 2013 Sep 21.

  PMID: 24063961 BACKGROUND

• Barr RG, Nakashima K, Amy D, Cosgrove D, Farrokh A, Schafer F, Bamber JC, Castera L, Choi BI, Chou YH, Dietrich CF, Ding H, Ferraioli G, Filice C, Friedrich-Rust M, Hall TJ, Nightingale KR, Palmeri ML, Shiina T, Suzuki S, Sporea I, Wilson S, Kudo M. WFUMB guidelines and recommendations for clinical use of ultrasound elastography: Part 2: breast. Ultrasound Med Biol. 2015 May;41(5):1148-60. doi: 10.1016/j.ultrasmedbio.2015.03.008. Epub 2015 Mar 18.

  PMID: 25795620 BACKGROUND

• Cosgrove DO, Berg WA, Dore CJ, Skyba DM, Henry JP, Gay J, Cohen-Bacrie C; BE1 Study Group. Shear wave elastography for breast masses is highly reproducible. Eur Radiol. 2012 May;22(5):1023-32. doi: 10.1007/s00330-011-2340-y. Epub 2011 Dec 31.

  PMID: 22210408 BACKGROUND

• Balleyguier C, Canale S, Ben Hassen W, Vielh P, Bayou EH, Mathieu MC, Uzan C, Bourgier C, Dromain C. Breast elasticity: principles, technique, results: an update and overview of commercially available software. Eur J Radiol. 2013 Mar;82(3):427-34. doi: 10.1016/j.ejrad.2012.03.001. Epub 2012 Mar 24.

  PMID: 22445593 BACKGROUND

• Barr RG, Destounis S, Lackey LB 2nd, Svensson WE, Balleyguier C, Smith C. Evaluation of breast lesions using sonographic elasticity imaging: a multicenter trial. J Ultrasound Med. 2012 Feb;31(2):281-7. doi: 10.7863/jum.2012.31.2.281.

  PMID: 22298872 BACKGROUND

• Barr RG. Sonographic breast elastography: a primer. J Ultrasound Med. 2012 May;31(5):773-83. doi: 10.7863/jum.2012.31.5.773.

  PMID: 22535725 BACKGROUND

• Evans A, Whelehan P, Thomson K, Brauer K, Jordan L, Purdie C, McLean D, Baker L, Vinnicombe S, Thompson A. Differentiating benign from malignant solid breast masses: value of shear wave elastography according to lesion stiffness combined with greyscale ultrasound according to BI-RADS classification. Br J Cancer. 2012 Jul 10;107(2):224-9. doi: 10.1038/bjc.2012.253. Epub 2012 Jun 12.

  PMID: 22691969 BACKGROUND

• Cai L, Pfob A, Barr RG, Duda V, Alwafai Z, Balleyguier C, Clevert DA, Fastner S, Gomez C, Goncalo M, Gruber I, Hahn M, Kapetas P, Nees J, Ohlinger R, Riedel F, Rutten M, Stieber A, Togawa R, Sidey-Gibbons C, Tozaki M, Wojcinski S, Heil J, Golatta M. Deep Learning Model for Breast Shear Wave Elastography to Improve Breast Cancer Diagnosis (INSPiRED 006): An International, Multicenter Analysis. J Clin Oncol. 2025 Nov 10;43(32):3482-3493. doi: 10.1200/JCO-24-02681. Epub 2025 Aug 20.

  PMID: 40834300 DERIVED

• Golatta M, Pfob A, Busch C, Bruckner T, Alwafai Z, Balleyguier C, Clevert DA, Duda V, Goncalo M, Gruber I, Hahn M, Kapetas P, Ohlinger R, Rutten M, Togawa R, Tozaki M, Wojcinski S, Rauch G, Heil J, Barr RG. The potential of combined shear wave and strain elastography to reduce unnecessary biopsies in breast cancer diagnostics - An international, multicentre trial. Eur J Cancer. 2022 Jan;161:1-9. doi: 10.1016/j.ejca.2021.11.005. Epub 2021 Dec 5.

  PMID: 34879299 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Elasticity Imaging Techniques; Ultrasonography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Michael Golatta, PD Dr. med., MHBA

  University of Heidelberg, Department of Gynecology, Breast Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: December 23, 2015
• Study Start: February 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 10, 2020

Record last verified: 2020-04

Locations

NL (1); FR (1); US (1); JP (1); PT (1); DE (6)