Clinical trial · Interventional
Realtime-Elastography (RTE) and Thyroid Nodules
Evaluation of Realtime-Elastography for Differentiation of Thyroid Nodules: a Multicenter Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Nodules | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytology (FNAB) or Surgery | Procedure | — | UNRESOLVED |
| Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Realtime-Elastography scores I-IV in thyroid nodules
- description
- 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)
- measure
- Comparison of Realtime-Elastography with B-mode and Duplex-Ultrasonography concerning the additional diagnostic information obtained by Realtime-Elastography
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available