Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation

Not Applicable

Recruiting

• Conditions: Thyroid Nodule
• Interventions: Procedure: Radiofrequency ablation performed with a 19 gauge STARmed needle.

• Registration Number: NCT05765695
• Lead Sponsor: Istituto Auxologico Italiano

Brief Summary

The goal of this clinical trial is to demonstrate that TIR3A nodules with negative genetic test can be safely and effectively treated by radiofrequency ablation, with nodular shrinkage and improvement of clinical symptoms.

Fine needle aspiration cytology is the gold standard test for differential diagnosis of thyroid nodules, but sometimes the result can be indeterminate with a risk of malignancy of 10-30%. In these cases the ablation is not indicated and many patients with benign nodules that may benefit from the procedure are not treated.

All the patients enrolled must have a TIR3A cytology and negative genetic test for mutations associated with thyroid carcinoma. Before the ablation blood, evaluation of serum TSH, anti-thyroglobulin antibodies, anti-thyroid peroxidase antibodies and calcitonin levels will be performed.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-10
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2025-01-10
• Study Completion: 2025-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with thyroid nodule eligible for radiofrequency ablation, with low-risk indeterminate lesion cytology (TIR3A) and negative genetic test for mutations associated with thyroid carcinoma

Exclusion Criteria

• Patients who are not able to sign the informed consent
• Patients with contraindications to radiofrequency ablation
• Patients with cytology different from TIR3A
• Patients with positive genetic test for mutations associated with thyroid carcinoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treated group	Radiofrequency ablation performed with a 19 gauge STARmed needle.	-

Primary Outcome Measures

Name	Time	Method
Complication rate	12 months after the procedure	Assessment of the complications of the procedure and over time
Thyroid nodule volume reduction rate	12 months after the procedure	The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline

Trial Locations

Locations (1)

Istituto Auxologico Italiano IRCCS; 🇮🇹 Milan, Italy