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Realtime-Elastography (RTE) and Thyroid Nodules

NCT01609946 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 602

Last updated 2018-04-02

No results posted yet for this study

Summary

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.

Conditions

  • Thyroid Nodules

Interventions

DEVICE

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

PROCEDURE

Cytology (FNAB) or Surgery

Sponsors & Collaborators

  • Johannes Vermehren

    lead OTHER

Principal Investigators

  • Joerg Bojunga, MD · Klinikum der J. W. Goethe-Universität, Frankfurt, Germany

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-12-31
Completion
2014-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01609946 on ClinicalTrials.gov