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Realtime-Elastography (RTE) and Thyroid Nodules

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ClinicalTrials.gov Identifier: NCT01609946
Recruitment Status : Unknown
Verified May 2012 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
First Posted : June 1, 2012
Last Update Posted : July 16, 2012
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Thyroid Nodules Device: Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan Procedure: Cytology (FNAB) or Surgery

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 593 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Realtime-Elastography for Differentiation of Thyroid Nodules: a Multicenter Study
Study Start Date : June 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Comparison of Realtime-Elastography with B-mode and Duplex-Ultrasonography concerning the additional diagnostic information obtained by Realtime-Elastography

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609946

Contact: Joerg Bojunga, MD 49696301 ext 87686 Joerg.Bojunga@kgu.de
Contact: Mireen Friedrich-Rust, MD 49696301 ext 87686 Mireen.Friedrich-Rust@kgu.de

Caritas-Krankenhaus Recruiting
Bad Mergentheim, Germany
Klinikum Bielefeld Recruiting
Bielefeld, Germany
Klinikum der J. W. Goethe-Universität Recruiting
Frankfurt am Main, Germany
Contact: Joerg Bojunga, MD       Joerg.Bojunga@kgu.de   
Bürgerhospital Recruiting
Frankfurt, Germany
Helfenstein Klinik Recruiting
Geislingen, Germany
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany
Klinikum am Steinberg Recruiting
Reutlingen, Germany
Endokrinologie und Diabetologie im Zentrum Recruiting
Stuttgart, Germany
Universitätsklinikum Ulm Recruiting
Ulm, Germany
Deutsche Klinik für Diagnostik Recruiting
Wiesbaden, Germany
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Principal Investigator: Joerg Bojunga, MD Klinikum der J. W. Goethe-Universität, Frankfurt, Germany
More Information

ClinicalTrials.gov Identifier: NCT01609946     History of Changes
Other Study ID Numbers: JWGUHMED1-004
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: July 16, 2012
Last Verified: May 2012

Keywords provided by Johann Wolfgang Goethe University Hospital:
presenting for FNAB or surgery

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms