Realtime-Elastography (RTE) and Thyroid Nodules

Not Applicable

Completed

• Conditions: Thyroid Nodules

• Registration Number: NCT01609946
• Lead Sponsor: Johannes Vermehren

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-05-31
• Study Start: 2012-06
• Study First Posted: 2012-06-01
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-30
• Last Update Posted: 2018-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 602

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Comparison of Realtime-Elastography with B-mode and Duplex-Ultrasonography concerning the additional diagnostic information obtained by Realtime-Elastography

Trial Locations

Locations (10)

Klinikum am Steinberg; 🇩🇪 Reutlingen, Germany

Endokrinologie und Diabetologie im Zentrum; 🇩🇪 Stuttgart, Germany

Klinikum der J. W. Goethe-Universität; 🇩🇪 Frankfurt am Main, Germany

Bürgerhospital; 🇩🇪 Frankfurt, Germany

Klinikum Bielefeld; 🇩🇪 Bielefeld, Germany

Helfenstein Klinik; 🇩🇪 Geislingen, Germany

Deutsche Klinik für Diagnostik; 🇩🇪 Wiesbaden, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Caritas-Krankenhaus; 🇩🇪 Bad Mergentheim, Germany