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Realtime-Elastography (RTE) and Thyroid Nodules

Primary Purpose

Thyroid Nodules

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan
Cytology (FNAB) or Surgery
Sponsored by
Johannes Vermehren
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Nodules focused on measuring presenting for FNAB or surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Caritas-Krankenhaus
  • Klinikum Bielefeld
  • Klinikum der J. W. Goethe-Universität
  • Bürgerhospital
  • Helfenstein Klinik
  • Universitätsklinikum Leipzig
  • Klinikum am Steinberg
  • Endokrinologie und Diabetologie im Zentrum
  • Universitätsklinikum Ulm
  • Deutsche Klinik für Diagnostik

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
May 30, 2012
Last Updated
March 30, 2018
Sponsor
Johannes Vermehren
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1. Study Identification

Unique Protocol Identification Number
NCT01609946
Brief Title
Realtime-Elastography (RTE) and Thyroid Nodules
Official Title
Evaluation of Realtime-Elastography for Differentiation of Thyroid Nodules: a Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Johannes Vermehren

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodules
Keywords
presenting for FNAB or surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
602 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan
Intervention Type
Procedure
Intervention Name(s)
Cytology (FNAB) or Surgery
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Comparison of Realtime-Elastography with B-mode and Duplex-Ultrasonography concerning the additional diagnostic information obtained by Realtime-Elastography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joerg Bojunga, MD
Organizational Affiliation
Klinikum der J. W. Goethe-Universität, Frankfurt, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caritas-Krankenhaus
City
Bad Mergentheim
Country
Germany
Facility Name
Klinikum Bielefeld
City
Bielefeld
Country
Germany
Facility Name
Klinikum der J. W. Goethe-Universität
City
Frankfurt am Main
Country
Germany
Facility Name
Bürgerhospital
City
Frankfurt
Country
Germany
Facility Name
Helfenstein Klinik
City
Geislingen
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
Klinikum am Steinberg
City
Reutlingen
Country
Germany
Facility Name
Endokrinologie und Diabetologie im Zentrum
City
Stuttgart
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
Facility Name
Deutsche Klinik für Diagnostik
City
Wiesbaden
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Realtime-Elastography (RTE) and Thyroid Nodules

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