Realtime-Elastography (RTE) and Thyroid Nodules

Thyroid Nodules Clinical Trial

Official title:

Evaluation of Realtime-Elastography for Differentiation of Thyroid Nodules: a Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609946
• Other study ID #: JWGUHMED1-004
• Status: Completed
• Phase: N/A
• First received: May 30, 2012
• Last updated: March 30, 2018
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2018
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule
• Thyroid Nodules

Intervention

Device:
• Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan

Procedure:
• Cytology (FNAB) or Surgery

Locations

Country	Name	City	State
Germany	Caritas-Krankenhaus	Bad Mergentheim
Germany	Klinikum Bielefeld	Bielefeld
Germany	Bürgerhospital	Frankfurt
Germany	Klinikum der J. W. Goethe-Universität	Frankfurt am Main
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Vermehren

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	Comparison of Realtime-Elastography with B-mode and Duplex-Ultrasonography concerning the additional diagnostic information obtained by Realtime-Elastography