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RECRUITINGINTERVENTIONAL

Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Patients who are not able to sign the willing to sign a consent form - Patients with contraindications to radiofrequency ablation - Patients with cytology different from TIR3A - Patients with positive genetic test for mutations associated with thyroid carcinoma Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

Radiofrequency ablation performed with a 19 gauge STARmed needle.

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.

Locations (1)

Istituto Auxologico Italiano IRCCS
Milan, Italy