Clinical trial NCT05734326: Elastography and FNAC in Thyroid Nodule
Official title: Role of US Elastography Compared With FNAC in Diagnosis of Solitary Thyroid Nodule
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Nodule
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* all patients referred to radiology department presented clinically with solitary thyroid nodule .

Exclusion Criteria:

* patients previously underwent thyroid surgery
* patients with severe uncorrectable bleeding diathesis.
* Patients refused to sign consent.

Primary outcomes:
measure: Evaluate the accuracy of USE in comparison with FNAC in characterization of solitary thyroid nodule and assessment the risk of malignancy.
timeFrame: Base line
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohamed Gabeer, Professor
role: STUDY_DIRECTOR
References:
citation: 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.