Realtime-Elastography (RTE) and Thyroid Nodules

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

602 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Thyroid Nodules

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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

Intervention Type DEVICE

Cytology (FNAB) or Surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No