Realtime-Elastography (RTE) and Thyroid Nodules
|ClinicalTrials.gov Identifier: NCT01609946|
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : April 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Nodules||Device: Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan Procedure: Cytology (FNAB) or Surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||602 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Realtime-Elastography for Differentiation of Thyroid Nodules: a Multicenter Study|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2014|
- Realtime-Elastography scores I-IV in thyroid nodulesScores: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609946
|Bad Mergentheim, Germany|
|Klinikum der J. W. Goethe-Universität|
|Frankfurt am Main, Germany|
|Klinikum am Steinberg|
|Endokrinologie und Diabetologie im Zentrum|
|Deutsche Klinik für Diagnostik|
|Principal Investigator:||Joerg Bojunga, MD||Klinikum der J. W. Goethe-Universität, Frankfurt, Germany|