The study is an open, prospective multicenter study. According to the statistical sample size calculation 593 patients with thyroid nodules ≥ 5mm in size will be included in the study. Reference methods are cytology obtained by Fine needle aspiration biopsy (FNAB) or histology obtained by surgery. All patients will receive an B-mode and Duplex ultrasound examination of the thyroid gland, as well as Realtime Elastography of thyroid nodules. Results of B-mode and Duplex ultrasound are compared to Realtime Elastography to evaluate the additional value of Realtime Elastography in the diagnostic work up of thyroid nodules.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
602
Caritas-Krankenhaus
Bad Mergentheim, Germany
Klinikum Bielefeld
Bielefeld, Germany
Bürgerhospital
Frankfurt, Germany
Klinikum der J. W. Goethe-Universität
Frankfurt am Main, Germany
Realtime-Elastography scores I-IV in thyroid nodules
Scores: I-II: benign; III-IV: malignant nodules. The sensitivity and specificity of Realtime-Elastography for the diagnosis of malignant thyroid nodules will be calculated on the basis of above-specified criteria. Cytology is used as reference method for benign nodules and histology for malignant nodules.
Comparison of Realtime-Elastography with B-mode and Duplex-Ultrasonography concerning the additional diagnostic information obtained by Realtime-Elastography
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Helfenstein Klinik
Geislingen, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Klinikum am Steinberg
Reutlingen, Germany
Endokrinologie und Diabetologie im Zentrum
Stuttgart, Germany
Universitätsklinikum Ulm
Ulm, Germany
Deutsche Klinik für Diagnostik
Wiesbaden, Germany