Realtime-Elastography (RTE) and Thyroid Nodules

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01609946

Enrollment

602

Registered

2012-06-01

Start date

2012-06-30

Completion date

2014-12-31

Last updated

2018-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Nodules

Keywords

presenting for FNAB or surgery

Brief 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.

Interventions

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

PROCEDURECytology (FNAB) or Surgery

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026