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FNA inadequacyFactors Affecting Rapid Onsite Evaluation of Thyroid Nodule FNA Samples

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What is being tested

fine needle aspiration

Diagnostic Test
Who is being recruted

Endocrine System Diseases+4

+ Endocrine Gland Neoplasms

+ Head and Neck Neoplasms

Over 18 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorAssiut University
Study ContactRamy M Mohammed, MD of radiology
Last updated: February 4, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2025

Actual date on which the first participant was enrolled.

This study investigates why some thyroid nodule samples, obtained through a procedure called Fine Needle Aspiration (FNA), do not provide enough information for a clear diagnosis. Thyroid nodules are quite common, with many being harmless, but some can be cancerous. Using ultrasound, doctors can guide the FNA procedure to collect cells from the nodules. However, in some cases, the samples are inadequate, making it hard to determine if the nodule is benign or malignant. This study aims to explore various factors, such as the characteristics of the nodules and the techniques used, to improve the accuracy and effectiveness of these evaluations. Participants undergoing FNA for thyroid nodules will have their samples evaluated as part of this study. The procedure involves using a thin needle to collect cells from the thyroid nodule under ultrasound guidance. Researchers will analyze factors like needle size, characteristics of the nodule, and the sampling technique to determine what influences the adequacy of the samples. Improving these factors could lead to fewer repeat procedures, reducing patient discomfort and medical costs, while enhancing the accuracy of thyroid nodule diagnoses.

Official TitleFactors Influencing Inadequacy in Rapid Onsite Evaluation of Ultrasound Guided Fine Needle Aspiration (FNA) Samples of Thyroid Nodules
NCT06984991
Principal SponsorAssiut University
Study ContactRamy M Mohammed, MD of radiology
Last updated: February 4, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesEndocrine Gland NeoplasmsHead and Neck NeoplasmsNeoplasmsNeoplasms by SiteThyroid DiseasesThyroid Neoplasms

Criteria

1 inclusion criteria required to participate
Patients referred for FNA of thyroid nodules (TIRAD-3, 4 and 5 nodules).
1 exclusion criteria prevent from participating
History of thyroid ablation before FNA

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All FNAs will be performed by experienced radiologists (of 5-year experience in thyroid FNA procedures). Patients will be positioned comfortably, typically in a supine position with neck extension after putting a pillow under shoulders to fully expose the patient's neck to allow optimal access to the nodule. Ultrasound guidance using Logic E9 machine (GE Healthcare, Chicago, IL, USA) or Sonoscape X5 Portable Ultrasound machine with high-frequency linear array probes (3-12 MHz) will be used to visualize the nodule accurately and guide needle placement. 5ml syringe with 21G needle, 3ml syringe with 23G needle or 22G Quincke tip spinal needle will be used for FNA. Needle insertion will be directed either trans-isthmic or lateral cervical approach. Aspirations will be conducted at different angles and within different nodule regions using a to-and-fro motion till getting blood stain in the needle hub to obtain representative samples. Maximum number of four passes will be performed .

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Assiut University Hospital

Asyut, EgyptOpen Assiut University Hospital in Google Maps
Recruiting
One Study Center