Realtime-Elastography (RTE) and Thyroid Nodules

March 30, 2018 updated by: Johannes Vermehren

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

602

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Mergentheim, Germany
        • Caritas-Krankenhaus
      • Bielefeld, Germany
        • Klinikum Bielefeld
      • Frankfurt, Germany
        • Bürgerhospital
      • Frankfurt am Main, Germany
        • Klinikum der J. W. Goethe-Universität
      • Geislingen, Germany
        • Helfenstein Klinik
      • Leipzig, Germany
        • Universitätsklinikum Leipzig
      • Reutlingen, Germany
        • Klinikum am Steinberg
      • Stuttgart, Germany
        • Endokrinologie und Diabetologie im Zentrum
      • Ulm, Germany
        • Universitatsklinikum Ulm
      • Wiesbaden, Germany
        • Deutsche Klinik für Diagnostik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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

Outcome Measure
Comparison of Realtime-Elastography with B-mode and Duplex-Ultrasonography concerning the additional diagnostic information obtained by Realtime-Elastography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Vermehren

Investigators

  • Principal Investigator: Joerg Bojunga, MD, Klinikum der J. W. Goethe-Universität, Frankfurt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

May 31, 2012

First Posted (Estimate)

June 1, 2012

Study Record Updates

Last Update Posted (Actual)

April 2, 2018

Last Update Submitted That Met QC Criteria

March 30, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JWGUHMED1-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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