Realtime-Elastography (RTE) and Thyroid Nodules
This study is currently recruiting participants.
Verified May 2012 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Johann Wolfgang Goethe University Hospitals
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01609946
First received: May 30, 2012
Last updated: July 13, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Thyroid Nodules |
Device: Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan Procedure: Cytology (FNAB) or Surgery |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Evaluation of Realtime-Elastography for Differentiation of Thyroid Nodules: a Multicenter Study |
Resource links provided by NLM:
MedlinePlus related topics:
Thyroid Diseases
Drug Information available for:
Thyroid
U.S. FDA Resources
Further study details as provided by Johann Wolfgang Goethe University Hospitals:
Primary Outcome Measures:
- Realtime-Elastography scores I-IV in thyroid nodules [ Designated as safety issue: No ]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 Outcome Measures:
- Comparison of Realtime-Elastography with B-mode and Duplex-Ultrasonography concerning the additional diagnostic information obtained by Realtime-Elastography [ Designated as safety issue: No ]
| Estimated Enrollment: | 593 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609946
Contacts
| Contact: Joerg Bojunga, MD | 49696301 ext 87686 | Joerg.Bojunga@kgu.de |
| Contact: Mireen Friedrich-Rust, MD | 49696301 ext 87686 | Mireen.Friedrich-Rust@kgu.de |
Locations
| Germany | |
| Caritas-Krankenhaus | Recruiting |
| Bad Mergentheim, Germany | |
| Klinikum Bielefeld | Recruiting |
| Bielefeld, Germany | |
| Bürgerhospital | Recruiting |
| Frankfurt, Germany | |
| Klinikum der J. W. Goethe-Universität | Recruiting |
| Frankfurt am Main, Germany | |
| Contact: Joerg Bojunga, MD Joerg.Bojunga@kgu.de | |
| Helfenstein Klinik | Recruiting |
| Geislingen, Germany | |
| Universitätsklinikum Leipzig | Recruiting |
| Leipzig, Germany | |
| Klinikum am Steinberg | Recruiting |
| Reutlingen, Germany | |
| Endokrinologie und Diabetologie im Zentrum | Recruiting |
| Stuttgart, Germany | |
| Universitätsklinikum Ulm | Recruiting |
| Ulm, Germany | |
| Deutsche Klinik für Diagnostik | Recruiting |
| Wiesbaden, Germany | |
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
| Principal Investigator: | Joerg Bojunga, MD | Klinikum der J. W. Goethe-Universität, Frankfurt, Germany |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01609946 History of Changes |
| Other Study ID Numbers: | JWGUHMED1-004 |
| Study First Received: | May 30, 2012 |
| Last Updated: | July 13, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Johann Wolfgang Goethe University Hospitals:
|
presenting for FNAB or surgery |
Additional relevant MeSH terms:
|
Thyroid Diseases Thyroid Nodule Endocrine System Diseases Thyroid Neoplasms |
Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013