Thyroid NoduleNCT05734326
Elastography and FNAC in Thyroid Nodule
An observational study of Thyroid Nodule, run by Assiut University.
Trial summary
Evaluate the accuracy of USE in comparison with FNAC in characterization of solitary thyroid nodule and assessment the risk of malignancy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Ultrasound elastography
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Dec 2023
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients will be scanned with SWE, The thyroid gland carefully examined in the transverse and longitudinal dimensions with an 8-12 MHz linear array transducer. The shape, size, margin and echo-pattern of the lesions will be determined.then compared with FNAC results as the correct needle position inside the nodule and then in aspiration which, Finally elasticity scores and strain ratio calculations will be compared with FNAC results.
Who may be able to join
- all patients referred to radiology department presented clinically with solitary thyroid nodule .
Who cannot join
- patients previously underwent thyroid surgery
- patients with severe uncorrectable bleeding diathesis.
- Patients refused to sign consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of US Elastography Compared With FNAC in Diagnosis of Solitary Thyroid Nodule
Evaluate the accuracy of USE in comparison with FNAC in characterization of solitary thyroid nodule and assessment the risk of malignancy
Read the detailed description
Thyroid nodules occur commonly in the general population, mostly as incidental findings, with a prevalence of 19-68% at ultrasound (US) evaluation . However, although US is an established and very sensitive method for detecting thyroid nodule , it has a relatively low diagnostic performance when it comes to differentiating between benign and malignant nodules.
Therefore, when a patient presents with normal thyroid-stimulating hormone levels but US shows suspicious signs , a fine-needle aspiration biopsy (FNAB) is advised, fine-needle aspiration (FNA) is not a conclusive diagnostic method in all cases, considering its specificity, which ranges from 60 to 98%, and its variable sensitivity, which ranges from 54 to 90%, as well as the frequent eventual clinical need to repeat the test.
However, in consideration of the financial burden on health services, and to avoid unnecessary anxiety for patients, it is unrealistic to biopsy every thyroid nodule to obtain histological diagnosis.
In recent years, several studies have proposed the potential use of (US-elastography)to increase the accuracy of baseline US. Moreover, ultrasound elastography (USE) is emerging as a promising additional tool to discern malignant thyroid nodules, allowing increased diagnostic accuracy, especially in comparison with TIRADS (Thyroid Imaging Reporting and Data Systems). A firm or hard nodule consistency at palpation is associated with a high risk of malignancy. Due to its ability to assess stiffness as an indicator of malignancy, USE has recently become an additional tool for thyroid nodule differentiation, in combination with conventional US and FNA. In particular, strain ratio elastography (SRE) has shown high sensitivity and specificity, leading the EFSUMB (European Federation of Societies for Ultrasound in Medicine and Biology) to recommend that it should be part of the work-up of thyroid nodule characterization.
- Conditions
- Thyroid Nodule
- Being tested
- Ultrasound elastography
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound elastographyDevice
Also called FNAC
ultrasound elastography (USE) is emerging as a promising additional tool to discern malignant thyroid nodules, allowing increased diagnostic accuracy, Due to its ability to assess stiffness as an indicator of malignancy, USE has recently become an additional tool for thyroid nodule differentiation, in combination with conventional US and FNA [18].
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the accuracy of USE in comparison with FNAC in characterization of solitary thyroid nodule and assessment the risk of malignancy.
Patients will be scanned with SWE The thyroid gland carefully examined in the transverse and longitudinal dimensions with an 8-12 MHz linear array transducer.
Measured: Base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mosad Shenouda, Assiut University
- Investigators
- Mohamed Gabeer, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734326
- Sponsor's protocol ID
- Elastography & FNAC in thyroid
- Status last verified
- Feb 2023
- First submitted
- 3 Mar 2022
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fresilli D, David E, Pacini P, Del Gaudio G, Dolcetti V, Lucarelli GT, Di Leo N, Bellini MI, D'Andrea V, Sorrenti S, Mascagni D, Biffoni M, Durante C, Grani G, De Vincentis G, Cantisani V. Thyroid Nodule Characterization: How to Assess the Malignancy Risk. Update of the Literature. Diagnostics (Basel). 2021 Jul 30;11(8):1374. doi: 10.3390/diagnostics11081374.
PubMed 34441308
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of US Elastography Compared With FNAC in Diagnosis of Solitary Thyroid Nodule
- ClinicalTrials.gov ID
- NCT05734326
- Acronym / sponsor ID
- Elastography & FNAC in thyroid
- Conditions
- Thyroid Nodule
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 17 Feb 2023 (actual)
- 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.
Evaluate the accuracy of USE in comparison with FNAC in characterization of solitary thyroid nodule and assessment the risk of malignancy
Detailed description
Thyroid nodules occur commonly in the general population, mostly as incidental findings, with a prevalence of 19-68% at ultrasound (US) evaluation . However, although US is an established and very sensitive method for detecting thyroid nodule , it has a relatively low diagnostic performance when it comes to differentiating between benign and malignant nodules.
Therefore, when a patient presents with normal thyroid-stimulating hormone levels but US shows suspicious signs , a fine-needle aspiration biopsy (FNAB) is advised, fine-needle aspiration (FNA) is not a conclusive diagnostic method in all cases, considering its specificity, which ranges from 60 to 98%, and its variable sensitivity, which ranges from 54 to 90%, as well as the frequent eventual clinical need to repeat the test.
However, in consideration of the financial burden on health services, and to avoid unnecessary anxiety for patients, it is unrealistic to biopsy every thyroid nodule to obtain histological diagnosis.
In recent years, several studies have proposed the potential use of (US-elastography)to increase the accuracy of baseline US. Moreover, ultrasound elastography (USE) is emerging as a promising additional tool to discern malignant thyroid nodules, allowing increased diagnostic accuracy, especially in comparison with TIRADS (Thyroid Imaging Reporting and Data Systems). A firm or hard nodule consistency at palpation is associated with a high risk of malignancy. Due to its ability to assess stiffness as an indicator of malignancy, USE has recently become an additional tool for thyroid nodule differentiation, in combination with conventional US and FNA. In particular, strain ratio elastography (SRE) has shown high sensitivity and specificity, leading the EFSUMB (European Federation of Societies for Ultrasound in Medicine and Biology) to recommend that it should be part of the work-up of thyroid nodule characterization.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be scanned with SWE, The thyroid gland carefully examined in the transverse and longitudinal dimensions with an 8-12 MHz linear array transducer. The shape, size, margin and echo-pattern of the lesions will be determined.then compared with FNAC results as the correct needle position inside the nodule and then in aspiration which, Finally elasticity scores and strain ratio calculations will be compared with FNAC results.
Key inclusion criteria (1 listed)
- all patients referred to radiology department presented clinically with solitary thyroid nodule .
Key exclusion criteria (3 listed)
- patients previously underwent thyroid surgery
- patients with severe uncorrectable bleeding diathesis.
- Patients refused to sign consent.
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 |
|---|---|---|
| Ultrasound elastographyAlso: FNACultrasound elastography (USE) is emerging as a promising additional tool to discern malignant thyroid nodules, allowing increased diagnostic accuracy, Due to its ability to assess stiffness as an indicator of malignancy, USE has recently become an additional tool for thyroid nodule differentiation, in combination with conventional US and FNA [18]. | Device | – |
Primary outcome
Evaluate the accuracy of USE in comparison with FNAC in characterization of solitary thyroid nodule and assessment the risk of malignancy.
Time frame: Base line
Patients will be scanned with SWE The thyroid gland carefully examined in the transverse and longitudinal dimensions with an 8-12 MHz linear array transducer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Background: PubMed 34441308Fresilli D, David E, Pacini P, Del Gaudio G, Dolcetti V, Lucarelli GT, Di Leo N, Bellini MI, D'Andrea V, Sorrenti S, Mascagni D, Biffoni M, Durante C, Grani G, De Vincentis G, Cantisani V. Thyroid Nodule Characterization: How to Assess the Malignancy Risk. Update of the Literature. Diagnostics (Basel). 2021 Jul 30;11(8):1374. doi: 10.3390/diagnostics11081374.
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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.
Mohamed Gabeer, Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule, run by Assiut University.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam Mosad, Master Degree (01271195697, mariammosad475@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the accuracy of USE in comparison with FNAC in characterization of solitary thyroid nodule and assessment the risk of malignancy. (time frame: Base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05734326, which also lists 1 linked publication.
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 17 Feb 2023.