Realtime-Elastography (RTE) and Thyroid Nodules
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.
Device: Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan
Procedure: Cytology (FNAB) or Surgery
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Evaluation of Realtime-Elastography for Differentiation of Thyroid Nodules: a Multicenter Study|
- Realtime-Elastography scores I-IV in thyroid nodules [ Designated as safety issue: No ]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 [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609946
|Contact: Joerg Bojunga, MD||49696301 ext 87686||Joerg.Bojunga@kgu.de|
|Contact: Mireen Friedrich-Rust, MD||49696301 ext 87686||Mireen.Friedrich-Rust@kgu.de|
|Bad Mergentheim, Germany|
|Klinikum der J. W. Goethe-Universität||Recruiting|
|Frankfurt am Main, Germany|
|Contact: Joerg Bojunga, MD Joerg.Bojunga@kgu.de|
|Klinikum am Steinberg||Recruiting|
|Endokrinologie und Diabetologie im Zentrum||Recruiting|
|Deutsche Klinik für Diagnostik||Recruiting|
|Principal Investigator:||Joerg Bojunga, MD||Klinikum der J. W. Goethe-Universität, Frankfurt, Germany|