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

Completed · Not applicable

Conditions studied: Breast Neoplasms

In brief

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).

Key facts

Study ID: NCT02638935
Run by: Heidelberg University
People needed: 1304
Starts: 2016-02-01
Expected to finish: 2019-03-01
Last updated by the study team: 2020-04-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

Radiology Consultants, Inc. — Youngstown, Ohio, United States
Institut Gustave Roussy, Service de Radiologie, Villejuif Cedex — Villejuif, France
Franziskus Hospital — Bielefeld, Germany
Universitätsmedizin Greifswald, Klinik für Frauenheilkunde und Geburtshilfe — Greifswald, Germany
University of Heidelberg — Heidelberg, Germany
Universitätsklinikum Marburg, Klinik für Gynäkologie, gyn. Endokrinologie und Onkologie Senologische Diagnostik & Gynäkologischer Ultraschall — Marburg, Germany
LMU Klinikum der Universität München — München, Germany
Universitätsklinikum Tübingen — Tübingen, Germany
Sagara Hospital — Kagoshima, Matsubaracho, Kagoshima-shi, Japan
Jeroen Bosch Hospital — 's-Hertogenbosch, Netherlands
Centro Hospitalar e Universitário de Coimbra, Departamento de Radiologia — Coimbra, Portugal

Full record on ClinicalTrials.gov

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