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NCT Number: NCT01609946

Realtime-Elastography (RTE) and Thyroid Nodules

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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Key information

Conditions

Thyroid Nodules Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms Thyroid Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caritas-Krankenhaus, Bad Mergentheim, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan

Device

Cytology (FNAB) or Surgery

Procedure

Primary outcomes

  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 outcomes

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

Sponsors and collaborators

Lead sponsor

Johannes Vermehren

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 1, 2012
Registry last updated
Apr 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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