Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan | Device | |||
| Cytology (FNAB) or Surgery | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Realtime-Elastography with B-mode and Duplex-Ultrasonography concerning the additional diagnostic information obtained by Realtime-Elastography |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joerg Bojunga, MD | Klinikum der J. W. Goethe-Universität, Frankfurt, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caritas-Krankenhaus | Bad Mergentheim | Germany | ||||
| Klinikum Bielefeld |
Not provided
| ID | Term |
|---|---|
| D016606 | Thyroid Nodule |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bielefeld |
| Germany |
| Bürgerhospital | Frankfurt | Germany |
| Klinikum der J. W. Goethe-Universität | Frankfurt am Main | Germany |
| Helfenstein Klinik | Geislingen | Germany |
| Universitätsklinikum Leipzig | Leipzig | Germany |
| Klinikum am Steinberg | Reutlingen | Germany |
| Endokrinologie und Diabetologie im Zentrum | Stuttgart | Germany |
| Universitätsklinikum Ulm | Ulm | Germany |
| Deutsche Klinik für Diagnostik | Wiesbaden | Germany |
| D006258 |
| Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |