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

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ClinicalTrials.gov Identifier: NCT02638935
Recruitment Status : Unknown
Verified October 2017 by Michael Golatta, Heidelberg University.
Recruitment status was:  Recruiting
First Posted : December 23, 2015
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Siemens Medical Solutions
Information provided by (Responsible Party):
Michael Golatta, Heidelberg University

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).

Condition or disease Intervention/treatment Phase
Breast Neoplasms Device: Ultrasound- Virtual Touch Tissue Imaging Quantification Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : February 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
BI-RADS 3
Intervention: Ultrasound- Virtual Touch Tissue Imaging Quantification
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.
Other Names:
  • Elasticity Imaging
  • VTIQ
  • Elastography
  • Ultrasound
  • ARFI

BI-RADS 4a
Intervention: Ultrasound- Virtual Touch Tissue Imaging Quantification
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.
Other Names:
  • Elasticity Imaging
  • VTIQ
  • Elastography
  • Ultrasound
  • ARFI

BI-RADS 4b
Intervention: Ultrasound- Virtual Touch Tissue Imaging Quantification
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.
Other Names:
  • Elasticity Imaging
  • VTIQ
  • Elastography
  • Ultrasound
  • ARFI

BI-RADS 4c
Intervention: Ultrasound- Virtual Touch Tissue Imaging Quantification
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.
Other Names:
  • Elasticity Imaging
  • VTIQ
  • Elastography
  • Ultrasound
  • ARFI




Primary Outcome Measures :
  1. 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 [ Time Frame: 2 years ]

    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. Standard Binomial-test according to Bonferroni-Holm to test the null hypothesis H0_2 [ Time Frame: 2 years ]

    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%.


  3. Standard Binomial-test according to Bonferroni-Holm to test the null hypothesis H0_3 [ Time Frame: 2 years ]

    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%.



Secondary Outcome Measures :
  1. Corresponding chi-square tests for descriptive analysis of Virtual Touch Tissue Imaging Quantification (VTIQ) in the assessment of BI-RADS® 3, 4b, 4c lesions [ Time Frame: 2 years ]

    Equivalent hypotheses as given for primary outcome measures can be formulated for the patients finally staged as BI-RADS® 3, 4b and 4c. These hypotheses will be analyzed with corresponding chi-square tests, where the resulting p-values are only interpreted descriptively:

    To assess whether ultrasonically visualized breast lesions, categorized as BI-RADS® 3/ 4b/ 4c with a VTIQ-measured shear velocity value of smaller than 3.5 m/s (37 kPa), show a lower malignancy rate than BI-RADS® 3/ 4b/ 4c with a VTIQ-measured shear velocity value of larger than or equal to 3.5 m/s (37 kPa).


  2. BI-RADS® vs. BI-RADS® + Virtual Touch Tissue Imaging Quantification (VTIQ) [ Time Frame: 2 years ]
    Two logistic regression models including including BI-RADS® or BI-RADS® and VTIQ will be compared to test whether the probabilities for malignancies predicted with ultrasonically visualized breast lesions categorized as BI-RADS® differ from the probabilities for malignancies predicted with ultrasonically visualized breast lesions categorized as BI-RADS® and VTIQ-measured shear velocity.

  3. Corresponding chi-square tests for descriptive analysis of the strain ratio in the differentiation of BI-RADS® 3, 4a, 4b or 4c lesions [ Time Frame: 2 years ]
    Equivalent hypotheses as given in H0_1 vs H1_1 can be formulated for the patients initially staged as BI-RADS® 3, 4b and 4c. These hypotheses will be analyzed with corresponding chi-square tests, where the resulting p-values are only interpreted descriptively to test whether for women with ultrasonically visualized breast lesions categorized as BI-RADS® 3, 4a, 4b or 4c respectively, the subgroup of women with a strain ratio smaller than or equal to 1 shows a lower malignancy rate than the subgroup of women with a strain ratio of larger than 1.

  4. Robust regression models to test the INTRA-RATER reliability for the original continuous scale [ Time Frame: 2 years ]
    Robust regression models (Passing-Bablok-regression, orthogonal regression) and Bland-Altman Plots will be used for pairwise comparison of the continuous values between raters, where a slope of 1 and an intercept of 0 indicates agreement.

  5. Cohens's Kappa to test the INTRA-RATER reliability for the dichotomized values [ Time Frame: 2 years ]
  6. Robust regression models to test the INTER-RATER reliability for the original continuous scale [ Time Frame: 2 years ]
    Robust regression models (Passing-Bablok-regression, orthogonal regression) and Bland-Altman Plots will be used for pairwise comparison of the continuous values between raters, where a slope of 1 and an intercept of 0 indicates agreement.

  7. Cohens's Kappa to test the INTER-RATER reliability for the dichotomized values [ Time Frame: 2 years ]
  8. Descriptive analysis of predictive factors of the continuous VTIQ-value [ Time Frame: 2 years ]

    Thereby the following factors will be examined:

    Subject-related factors:

    • Skin - breast lesion surface depth (cm)
    • Quality factor (color coded scale) within the lesion
    • Breast density/ Tissue composition (homogeneous background texture fat, homogeneous background texture fibroglandular, heterogeneous background texture)
    • Lesion size in B-mode (cm)
    • Normal fatty tissue shear wave velocity (Ratio between measurement in the fatty tissue and in the lesion)
    • Pathology (fibroadenoma, lipoma, atypia, cyst condense, "non special type" (NST), invasive lobular carcinoma (ILC), invasive tubular carcinoma (ITC), carcinoma with medullary features, papillary cancer, ductal carcinoma in situ (DCIS), others)
    • Grading (G1, G2, G3, Gx)
    • Immunohistology (estrogen receptor (ER) status positive/ negative, progesterone receptor (PgR) status positive/ negative, human epidermal growth factor receptor 2 (HER2-neu) status positive/ negative, Ki-67 status (%))

  9. Skin to breast lesion surface depth (cm) [ Time Frame: 2 years ]

    For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

    Thereby one factor to be examined is the skin - breast lesion surface depth (cm).


  10. Quality factor within the lesion assessed using a color coded scale [ Time Frame: 2 years ]

    For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

    Thereby one factor to be examined is the Quality factor (color coded scale) within the lesion.


  11. Breast density/ tissue composition assessed using the morphologic characteristics on US (homogeneous background texture fat, homogeneous background texture fibroglandular, heterogeneous background texture) [ Time Frame: 2 years ]

    For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

    Thereby one factor to be examined is the breast density/ tissue composition (homogeneous background texture fat, homogeneous background texture fibroglandular, heterogeneous background texture).


  12. Lesion size in B-mode Ultrasound (in cm) [ Time Frame: 2 years ]

    For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

    Thereby one factor to be examined is the lesion size in B-mode (cm).


  13. Normal fatty tissue shear wave velocity (ratio between measurement in the fatty tissue and in the lesion) [ Time Frame: 2 years ]

    For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

    Thereby one factor to be examined is the normal fatty tissue shear wave velocity (ratio between measurement in the fatty tissue and in the lesion).


  14. Pathology (fibroadenoma, lipoma, atypia, cyst condense, "non special type" (NST), invasive lobular carcinoma (ILC), invasive tubular carcinoma (ITC), carcinoma with medullary features, papillary cancer, ductal carcinoma in situ (DCIS), others) [ Time Frame: 2 years ]

    For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

    Thereby one factor to be examined is the pathology (fibroadenoma, lipoma, atypia, cyst condense, "non special type" (NST), invasive lobular carcinoma (ILC), invasive tubular carcinoma (ITC), carcinoma with medullary features, papillary cancer, ductal carcinoma in situ (DCIS), others).


  15. Grading (G1, G2, G3, Gx) [ Time Frame: 2 years ]

    For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

    Thereby one factor to be examined is the grading (G1, G2, G3, Gx).


  16. Immunohistology (estrogen receptor (ER) status positive/ negative, progesterone receptor (PgR) status positive/ negative, human epidermal growth factor receptor 2 (HER2-neu) status positive/ negative, Ki-67 status (%)) [ Time Frame: 2 years ]

    For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

    Thereby one factor to be examined is the immunohistology (estrogen receptor (ER) status positive/ negative, progesterone receptor (PgR) status positive/ negative, human epidermal growth factor receptor 2 (HER2-neu) status positive/ negative, Ki-67 status (%)).


  17. Cohens's Kappa to determine the inter-rater reliability of BI-RADS® Assessment (local vs. central assessment) [ Time Frame: 2 years ]

    Local (BI-RADS® given at each site) and central expert BI-RADS® assessment will be compared (BI-RADS® assessment and assessment of the variables leading to the BI-RADS® value separately).

    To test the inter-rater reliability of BI-RADS® Assessment Cohens' Kappa will be calculated.


  18. Interclass correlation coefficient (ICC) values to determine the inter-rater reliability of BI-RADS® Assessment (local vs. central assessment) [ Time Frame: 2 years ]
    Local (BI-RADS® given at each site) and central expert BI-RADS® assessment will be compared (BI-RADS® assessment and assessment of the variables leading to the BI-RADS® value separately). To test the inter-rater reliability of BI-RADS® Assessment ICC values will be calculated.

  19. BI-RADS® vs. histological results [ Time Frame: 2 years ]
    To compare the BI-RADS® assessments with the histological results, the malignancy rates will be computed separately for each BI-RADS® value. It will then be checked whether these rates lie within the given intervals. Furthermore, the likelihood of malignancy estimated by the experts will be examined using receiver operating curve (ROC) and area under the curve (AUC).

  20. Chi-square test to examine whether the cut-off value of ≥ 3.5 m/s (37kPa) might be increased by increasing the cut-off value step-by-step by a small amount and repeat the primary analysis [ Time Frame: 2 years ]
    We will increase the cut-off value step-by-step by a small amount and repeat the primary analysis (using a chi-square test). We stop the testing procedure as soon as the p-value is above the significance level (0.05). This analysis is, obviously, only an explorative one and has no confirmatory value.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638935


Contacts
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Contact: Michael Golatta, PD Dr. med., MHBA +49 (0)6221 56-7906 michael.golatta@med.uni-heidelberg.de

Locations
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United States, Ohio
Radiology Consultants, Inc. Recruiting
Youngstown, Ohio, United States, 44512
Contact: Richard Barr, MD         
France
Institut Gustave Roussy, Service de Radiologie, Villejuif Cedex Recruiting
Villejuif, France
Contact: Corinne Balleyguier, Dr.       corinne.balleyguier@gustaveroussy.fr   
Germany
Franziskus Hospital Recruiting
Bielefeld, Germany, 33615
Contact: Sebastian Wojcinski, PD Dr. med.         
Universitätsmedizin Greifswald, Klinik für Frauenheilkunde und Geburtshilfe Recruiting
Greifswald, Germany, 17475
Contact: Ralf Ohlinger, Prof.Dr.med.         
University of Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Michael Golatta, PD Dr. med.         
Universitätsklinikum Marburg, Klinik für Gynäkologie, gyn. Endokrinologie und Onkologie Senologische Diagnostik & Gynäkologischer Ultraschall Not yet recruiting
Marburg, Germany, 35033
Contact: Volker Duda, Dr.       duda@med.uni-marburg.de   
LMU Klinikum der Universität München Recruiting
München, Germany, 81377
Contact: Dirk- André Clevert, Prof. Dr. med.         
Contact: Dorothea Rjosk- Dendorfer, Dr. med.         
Universitätsklinikum Tübingen Recruiting
Tubingen, Germany, 72076
Contact: Markus Hahn, Prof.Dr.med.         
Contact: Ines Gruber, Dr. med.         
Japan
Sagara Hospital Recruiting
Kagoshima, Matsubaracho, Kagoshima-shi, Japan
Contact: Tozaki Mitsuhiro, Dr.         
Netherlands
Jeroen Bosch Hospital Recruiting
's-Hertogenbosch, Netherlands, GZ5223
Contact: Matthieu Rutten, Dr.         
Portugal
Centro Hospitalar e Universitário de Coimbra, Departamento de Radiologia Recruiting
Coimbra, Portugal, 3000-075
Contact: Manuela Goncalo, Dr.       manuela_goncalo@hotmail.com   
Contact: Pedron Belo Oliveira, Dr.       pedronboliveira@gmail.com   
Principal Investigator: Pedron Belo Oliveira, Dr.         
Sponsors and Collaborators
Heidelberg University
Siemens Medical Solutions
Investigators
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Principal Investigator: Michael Golatta, PD Dr. med., MHBA University of Heidelberg, Department of Gynecology, Breast Unit

Publications:

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Responsible Party: Michael Golatta, PD Dr. med., Heidelberg University
ClinicalTrials.gov Identifier: NCT02638935     History of Changes
Other Study ID Numbers: VTIQ
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Michael Golatta, Heidelberg University:
Virtual Touch Tissue Imaging
VTIQ
Elastography
Breast Cancer
BI-RADS
Differentiation of breast lesions
Breast Lesion
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases