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Realtime-Elastography (RTE) and Thyroid Nodules

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier:
NCT01609946
First received: May 30, 2012
Last updated: July 13, 2012
Last verified: May 2012
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Realtime-Elastography for Differentiation of Thyroid Nodules: a Multicenter Study

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospital:

Primary Outcome Measures:
  • Realtime-Elastography scores I-IV in thyroid nodules [ Designated as safety issue: No ]
    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:
  • Comparison of Realtime-Elastography with B-mode and Duplex-Ultrasonography concerning the additional diagnostic information obtained by Realtime-Elastography [ Designated as safety issue: No ]

Estimated Enrollment: 593
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Johann Wolfgang Goethe University Hospital
Investigators
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 
Study First Received: May 30, 2012
Last Updated: July 13, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on December 07, 2016