Elastography and FNAC in Thyroid Nodule

NCT ID: NCT05734326

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-12-01

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.

Conditions

Thyroid Nodule

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

Ultrasound elastography

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 \[18\].

Intervention Type: DEVICE

Other Intervention Names

FNAC

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mariam Mosad Shenouda

Radiology professor Ahmed mostafa

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Gabeer, Professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Mariam Mosad, Master Degree

Role: CONTACT

mariammosad475@gmail.com

01271195697

Ahmed Mostafa, Professor

Role: CONTACT

moustafamanar@gmail.com

01000024182

References

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.

Reference Type: BACKGROUND

PMID: 34441308 (View on PubMed)

Other Identifiers

Elastography & FNAC in thyroid

Identifier Type: -

Identifier Source: org_study_id