Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation

Istituto Auxologico Italiano

Status

Enrolling

Conditions

Thyroid Nodule

Treatments

Procedure: Radiofrequency ablation performed with a 19 gauge STARmed needle.

Study type

Interventional

Funder types

Other

Identifiers

NCT05765695

05C023

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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