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NCT Number: NCT06984991

Factors Influencing Inadequacy in Rapid Onsite Evaluation of Ultrasound Guided Fine Needle Aspiration (FNA) Samples of Thyroid Nodules

Thyroid nodules are a common clinical finding with a prevalence of around 50-67% in the general population using ultrasound examinations. Of these, malignancies account for 5-15% including the treatable papillary and follicular thyroid carcinomas and the rarer but more aggressive medullary and undifferentiated thyroid cancers.

Fine Needle Aspiration (FNA) is a relatively simple, cost-effective recommended standard diagnostic procedure with high sensitivity and specificity for the preoperative evaluation of benign and malignant thyroid nodules.

Cytopathology reports of thyroid FNA are categorized using a universal grading system, which helps to standardize reporting of diagnostic thyroid cytology results. In the non-diagnostic/unsatisfactory category (Bethesda I), ranging from 1% to 20% of samples, pathologists are unable to make a clinical diagnosis based on these samples due to an inadequate number of cells or difficulty in identifying cells. The estimated risk of malignancy in this category is 1-4 %, which usually managed by repeating FNA with increase in patient discomfort, procedural complications and medical costs.

There are few other prospective studies investigated the effect of needle size, and sampling technique on sample adequacy.

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location status: Recruiting

Location contact

ramy M MOhammed, consultant of radiology

CONTACT

[email protected]

00201153070865

ramy M Mohammed

PRINCIPAL_INVESTIGATOR

About this study

Thyroid nodules are a common clinical finding with a prevalence of around 50-67% in the general population using ultrasound examinations. Of these, malignancies account for 5-15% including the treatable papillary and follicular thyroid carcinomas and the rarer but more aggressive medullary and undifferentiated thyroid cancers.

The American Thyroid Association has devised an algorithm "Thyroid Imaging Reporting and Data System (TI-RADS) for evaluation and management of thyroid nodules based on US pattern and size to recommend fine needle aspiration (FNA) cytology to minimize unnecessary FNAs/thyroid surgeries for nodules that are most likely benign and to avoid over-treating micropapillary thyroid carcinoma which is indolent. Fine Needle Aspiration (FNA) is a relatively simple, cost-effective recommended standard diagnostic procedure with high sensitivity and specificity for the preoperative evaluation of benign and malignant thyroid nodules.

Cytopathology reports of thyroid FNA are categorized using a universal grading system called The Bethesda System for Reporting Thyroid Cytopathology, which helps to standardize reporting of diagnostic thyroid cytology results [3]. In the non-diagnostic/unsatisfactory category (Bethesda I), ranging from 1% to 20% of samples, pathologists are unable to make a clinical diagnosis based on these samples due to an inadequate number of cells or difficulty in identifying cells. The estimated risk of malignancy in this category is 1-4 %, which usually managed by repeating FNA with increase in patient discomfort, procedural complications and medical costs.

Several retrospective and prospective studies investigated the factors associated with non-diagnostic samples rates, most of which focused on ultrasound guidance, the rapid on-site cytological evaluation and cystic components of the nodule. However, there are few other prospective studies investigated the other nodule characteristics, needle size, and sampling technique.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients referred for FNA of thyroid nodules (TIRAD-3, 4 and 5 nodules).

Exclusion criteria

  • History of thyroid ablation before FNA

Treatment and study plan

fine needle aspiration

Diagnostic Test

Different needle sizes will be used in FNA sampling ; 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 within the nodule in a single session. Samples will be primarily obtained without suction via the capillary method. However, aspiration with suction will be applied if no aspirates could be obtained in the needle hub after routine capillary method. For mixed cystic solid lesions; FNA will be done from the solid component after aspiration of the cystic component

Primary outcomes

  1. rate of sample adequacy

    Time frame: Day 1

    Aspirated material will be expelled onto glass slides, which will be immediately fixed and stained for cytological analysis. Rapid On-Site Evaluation (ROSE) will be utilized to assess the sample adequacy during the procedure using the diff-quik (air-dried) slides, allowing for additional passes if necessary. In this situation, ROSE is not used for bedside diagnosis.

    An experienced pathologist reported the ical diagnosis/reporfinal cytologt only once the entire case (i.e. all of the slides) are reviewed according to the Bethesda criteria.:

    (I) nondiagnostic (ND) (fewer than six groups of well-visualized follicular cells, each group containing less than 10 well-preserved epithelial cells); (II) benign lesion; (III) atypia of undetermined significance/follicular lesion of undetermined significance (AUS/FLUS); (IV) follicular neoplasm/suspicious for follicular neoplasm (FN/SFN); (V) suspicious for malignancy; and (VI) malignancy.

Study contacts

Contact information is provided by the study sponsor or research team.

Ramy M Mohammed, MD of radiology

CONTACT

[email protected]

+201153070865

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Acronym: FNA inadequacy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 22, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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