Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005544

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005544
  •   2014/03/11
  •   2012/05/30
  •   yes
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Secondary IDs

  •   NCT01609946  (ClinicalTrials.gov)
  •   JWGUHMED1-004  (Johann Wolfgang Goethe University Hospitals)
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Health Condition or Problem studied

  •   Thyroid Nodules
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Interventions/Observational Groups

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

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
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Primary Outcome

- 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.

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2012/06/30
  •   593
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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Exclusion Criteria

- Diseases which preclude study accomplishment or put the patient at any risk (e.g.
psychiatric diseases)

- Non-contractually capable persons

- Pregnancy

- Lactation

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Addresses

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    • Johann Wolfgang Goethe University Hospitals
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    • Klinikum der J. W. Goethe-Universität, Frankfurt, Germany
    • Joerg Bojunga, MD 
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    • Joerg Bojunga, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.