RecruitingNot ApplicableNCT05765695

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

Sponsor

Istituto Auxologico Italiano

Enrollment

30 participants

Start Date

Jan 10, 2021

Study Type

INTERVENTIONAL

Conditions

Thyroid Nodule

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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study looks at whether a non-surgical heat treatment called radiofrequency ablation can safely treat uncertain thyroid nodules (lumps in the thyroid that aren't clearly cancerous or benign), particularly when genetic tests show no cancer-related mutations. **You may be eligible if...** - You have a thyroid nodule classified as "indeterminate" (uncertain) on biopsy (TIR3A category) - Your genetic test for thyroid cancer mutations came back negative - You are considered a suitable candidate for radiofrequency ablation **You may NOT be eligible if...** - You are unable to provide informed consent - You have medical reasons that prevent you from having radiofrequency ablation - Your biopsy result is different from TIR3A - Your genetic test was positive for cancer-related mutations Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERadiofrequency 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

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NCT05765695

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