Thyroid NodulesNCT01609946
Realtime-Elastography (RTE) and Thyroid Nodules
A study testing Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan and Cytology (FNAB) or Surgery in people with Thyroid Nodules, run by Johannes Vermehren at 10 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodules
- What is being tested?
- Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan and Cytology (FNAB) or Surgery
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 602 participants
- Where
- 10 sitesGermany
- Study dates
- Jun 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)
- Non-contractually capable persons
- Pregnancy
- Lactation
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Caritas-Krankenhaus
Bad Mergentheim
Klinikum Bielefeld
Bielefeld
Bürgerhospital
Frankfurt
Klinikum der J. W. Goethe-Universität
Frankfurt am Main
Helfenstein Klinik
Geislingen
Universitätsklinikum Leipzig
Leipzig
Klinikum am Steinberg
Reutlingen
Endokrinologie und Diabetologie im Zentrum
Stuttgart
Universitätsklinikum Ulm
Ulm
Deutsche Klinik für Diagnostik
Wiesbaden
About this study
Official title: Evaluation of Realtime-Elastography for Differentiation of Thyroid Nodules: a Multicenter Study
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
- Being tested
- Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan, Cytology (FNAB) or Surgery
- Keywords
- presenting for FNAB or surgery
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, JapanDevice
Cytology (FNAB) or SurgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 602 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Vermehren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Johannes Vermehren, Johann Wolfgang Goethe University Hospital
- Investigators
- Joerg Bojunga, MD, Principal investigator, Klinikum der J. W. Goethe-Universität, Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609946
- Sponsor's protocol ID
- JWGUHMED1-004
- Status last verified
- Mar 2018
- First submitted
- 30 May 2012
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Realtime-Elastography for Differentiation of Thyroid Nodules: a Multicenter Study
- ClinicalTrials.gov ID
- NCT01609946
- Acronym / sponsor ID
- JWGUHMED1-004
- Conditions
- Thyroid Nodules
- Keywords
- presenting for FNAB or surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (estimated)
- Lead sponsor
- Johannes VermehrenUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)
- Non-contractually capable persons
- Pregnancy
- Lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan | Device | – |
| Cytology (FNAB) or Surgery | Procedure or surgery | – |
Primary outcome
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.
1 secondary outcome
Comparison of Realtime-Elastography with B-mode and Duplex-Ultrasonography concerning the additional diagnostic information obtained by Realtime-Elastography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
Related trials for Thyroid Nodules
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
RecruitingObservational study
International PPB/DICER1 Registry
Pleuropulmonary Blastoma, Sertoli-Leydig Cell Tumor
Recruiting
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Thyroid Gland Carcinoma
Active, not recruiting
Thyroid Nodule Gene Sequencing in a Danish Population
Thyroid Nodule (Diagnosis), Thyroid Cancer
RecruitingObservational study
Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy
Thyroid Cancer, Thyroid Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joerg Bojunga, MD principal investigator
Klinikum der J. W. Goethe-Universität, Frankfurt, Germany
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan and Cytology (FNAB) or Surgery in people with Thyroid Nodules, run by Johannes Vermehren at 10 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Realtime-Elastography scores I-IV in thyroid nodules. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2018.