Realtime-Elastography (RTE) and Thyroid Nodules
Conditions
Thyroid Nodules
Conditions: official terms
Thyroid Diseases - Thyroid Nodule
Conditions: Keywords
presenting for FNAB or surgery
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan Type: Device
Name: Cytology (FNAB) or Surgery Type: Procedure
Overall Status
Recruiting
Summary
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
Locations
Caritas-Krankenhaus
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 - Joerg.Bojunga@kgu.de
Bürgerhospital
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
Sponsors
Johann Wolfgang Goethe University Hospitals
Source
Johann Wolfgang Goethe University Hospitals
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page