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Realtime-Elastography (RTE) and Thyroid Nodules

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ClinicalTrials.gov Identifier: NCT01609946
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Johannes Vermehren, Johann Wolfgang Goethe University Hospital

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 Phase
Thyroid Nodules Device: Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan Procedure: Cytology (FNAB) or Surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 602 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
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

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




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


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

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


Locations
Germany
Caritas-Krankenhaus
Bad Mergentheim, Germany
Klinikum Bielefeld
Bielefeld, Germany
Klinikum der J. W. Goethe-Universität
Frankfurt am Main, Germany
Bürgerhospital
Frankfurt, 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, Germany
Sponsors and Collaborators
Johannes Vermehren
Investigators
Principal Investigator: Joerg Bojunga, MD Klinikum der J. W. Goethe-Universität, Frankfurt, Germany

Responsible Party: Johannes Vermehren, Record Keeper, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT01609946     History of Changes
Other Study ID Numbers: JWGUHMED1-004
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018

Keywords provided by Johannes Vermehren, 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
Neoplasms
Head and Neck Neoplasms