Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation

Sponsor

Istituto Auxologico Italiano (Other)

Overall Status

Recruiting

CT.gov ID

NCT05765695

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Nodule	Procedure: Radiofrequency ablation performed with a 19 gauge STARmed needle.	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 10, 2021

Anticipated Primary Completion Date :

Jan 10, 2024

Anticipated Study Completion Date :

Jan 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treated group	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.

Arm

Intervention/Treatment

Experimental: Treated group

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.

Outcome Measures

Primary Outcome Measures

Thyroid nodule volume reduction rate [1 month after the procedure]
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Thyroid nodule volume reduction rate [6 months after the procedure]
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Thyroid nodule volume reduction rate [12 months 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
Complication rate [1 month after the procedure]
Assessment of the complications of the procedure and over time
Complication rate [6 months after the procedure]
Assessment of the complications of the procedure and over time
Complication rate [12 months after the procedure]
Assessment of the complications of the procedure and over time

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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