Realtime-Elastography (RTE) and Thyroid Nodules

NCT01609946 | Completed

• 1 other identifier: JWGUHMED1-004
• Study Type: interventional
• Target: 602
• Locations: 1 country
• Sites: 10

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.

Conditions

Thyroid Nodules

Keywords

presenting for FNAB or surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of Realtime-Elastography with B-mode and Duplex-Ultrasonography concerning the additional diagnostic information obtained by Realtime-Elastography

Interventions

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

Cytology (FNAB) or Surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)
• Non-contractually capable persons
• Pregnancy
• Lactation

Sponsors & Collaborators

• Johannes Vermehren: lead

Study Sites (10)

Caritas-Krankenhaus

Bad Mergentheim, Germany

Location

Klinikum Bielefeld

Bielefeld, Germany

Location

Bürgerhospital

Frankfurt, Germany

Location

Klinikum der J. W. Goethe-Universität

Frankfurt am Main, Germany

Location

Helfenstein Klinik

Geislingen, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Klinikum am Steinberg

Reutlingen, Germany

Location

Endokrinologie und Diabetologie im Zentrum

Stuttgart, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Deutsche Klinik für Diagnostik

Wiesbaden, Germany

Location

MeSH Terms

Conditions

Thyroid Nodule

Interventions

Cytological Techniques

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Joerg Bojunga, MD

  Klinikum der J. W. Goethe-Universität, Frankfurt, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Record Keeper

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 1, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

DE (10)