Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation

Study Overview
=================
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.

Official Title
-----------------
Radiofrequency Ablation for Treating Thyroid Nodules Classified as TIR3A, With a Negative Genetic Evaluation for Thyroid Carcinoma

Conditions
-----------------
Thyroid Nodule

Intervention / Treatment
-----------------
* Procedure: Radiofrequency ablation performed with a 19 gauge STARmed needle.


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated group<br> | Procedure: Radiofrequency ablation performed with a 19 gauge STARmed needle.<br>* The ablation with radiofrequency is a safe and effective minimally invasive procedure that results in thermal tissue necrosis. A needle electrode is inserted into the thyroid nodule using ultrasound guidance and generates heat by alternating electric current causing thermal injury. Afterwards, the ablated tissue is gradually absorbed with progressive shrinkage of the nodule.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thyroid nodule volume reduction rate | The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline | 1 month after the procedure | 
| Thyroid nodule volume reduction rate | The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline | 6 months after the procedure | 
| Thyroid nodule volume reduction rate | The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline | 12 months after the procedure | 
| Complication rate | Assessment of the complications of the procedure and over time | When the procedure is performed | 
| Complication rate | Assessment of the complications of the procedure and over time | 1 month after the procedure | 
| Complication rate | Assessment of the complications of the procedure and over time | 6 months after the procedure | 
| Complication rate | Assessment of the complications of the procedure and over time | 12 months after the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroid nodule, indeterminate, genetic, radiofrequency ablation, follow-up