Why immediate on-site checks can be inadequate for ultrasound-guided thyroid nodule needle biopsies
Factors Influencing Inadequacy in Rapid Onsite Evaluation of Ultrasound Guided Fine Needle Aspiration (FNA) Samples of Thyroid Nodules
NA · Assiut University · NCT06984991
This project will try to identify which clinical, ultrasound, and procedural factors lead to inadequate rapid on-site evaluations of ultrasound-guided fine-needle biopsies in people having thyroid nodule FNA.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assiut University (other) |
| Locations | 1 site (Asyut, Asyut Governorate) |
| Trial ID | NCT06984991 on ClinicalTrials.gov |
What this trial studies
Patients referred for ultrasound-guided fine-needle aspiration (FNA) of TI-RADS 3–5 thyroid nodules will undergo standard FNA with rapid on-site evaluation (ROSE) of sample adequacy. The study will record nodule ultrasound features, number of needle passes, needle type, operator experience, and whether ROSE is performed by a cytopathologist or cytotechnologist. Researchers will compare rates of non-diagnostic (Bethesda I) samples across these factors to identify associations with inadequate ROSE. Findings will be analyzed to suggest procedural or workflow changes to reduce inadequate sampling and repeat procedures.
Who should consider this trial
Good fit: People referred for ultrasound-guided FNA of TI-RADS 3, 4, or 5 thyroid nodules who have not had prior thyroid ablation are ideal candidates.
Not a fit: Patients who have had prior thyroid ablation or who are not undergoing ultrasound-guided FNA would not be expected to benefit from this study's findings.
Why it matters
Potential benefit: If successful, this could lower the rate of non-diagnostic FNAs, reducing repeat procedures and speeding definitive diagnosis for patients with thyroid nodules.
How similar studies have performed: Prior studies of rapid on-site evaluation and procedural factors have shown mixed results, with some centers reducing nondiagnostic rates and others finding little change, so specific local factors remain important to study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients referred for FNA of thyroid nodules (TIRAD-3, 4 and 5 nodules). Exclusion Criteria: * History of thyroid ablation before FNA
Where this trial is running
Asyut, Asyut Governorate
- Assiut University Hospital — Asyut, Asyut Governorate, Egypt (RECRUITING)
Study contacts
- Study coordinator: Ramy M Mohammed, MD of radiology
- Email: ramycolor@aun.edu.eg
- Phone: +201153070865
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thyroid Cancer, thyroid FNA