Thyroid Nodule
Conditions
Keywords
thyroid nodule, indeterminate, genetic, radiofrequency ablation, follow-up
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.
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.
Sponsors
Istituto Auxologico Italiano
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thyroid nodule volume reduction rate | 1 month after the procedure | The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline |
| Complication rate | When the procedure is performed | Assessment of the complications of the procedure and over time |
Countries
Italy
Contacts
Primary ContactLaura Fugazzola
Outcome results
None listed