Realtime-Elastography (RTE) and Thyroid Nodules
Thyroid Nodules
Conditions: official terms
Thyroid Diseases - Thyroid Nodule
Conditions: Keywords
presenting for FNAB or surgery
Study Type
Study Phase
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Name: Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan Type: Device
Name: Cytology (FNAB) or Surgery Type: Procedure
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- patients with thyroid nodules ≥ 5mm in size and TSH ≥ 0,35µU/ml

- Cytology obtained by FNAB or thyroid surgery planned

- age ≥ 18 year

- signed written consent

Exclusion Criteria:

- Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)

- Non-contractually capable persons

- Pregnancy

- Lactation
Bad Mergentheim, Germany
Status: Recruiting
Klinikum Bielefeld
Bielefeld, Germany
Status: Recruiting
Klinikum der J. W. Goethe-Universität
Frankfurt am Main, Germany
Status: Recruiting
Contact: Joerg Bojunga, MD -
Frankfurt, Germany
Status: Recruiting
Helfenstein Klinik
Geislingen, Germany
Status: Recruiting
Universitätsklinikum Leipzig
Leipzig, Germany
Status: Recruiting
Klinikum am Steinberg
Reutlingen, Germany
Status: Recruiting
Endokrinologie und Diabetologie im Zentrum
Stuttgart, Germany
Status: Recruiting
Universitätsklinikum Ulm
Ulm, Germany
Status: Recruiting
Deutsche Klinik für Diagnostik
Wiesbaden, Germany
Status: Recruiting
Start Date
June 2012
Completion Date
December 2014
Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospitals
Record processing date processed this data on July 28, 2015 page