Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation

Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05765695
• Other study ID #: 05C023
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2021
• Est. completion date: January 10, 2025

Study information

• Verified date: April 2024
• Source: Istituto Auxologico Italiano
• Contact: Laura Fugazzola
• Phone: +390261911
• Email: l.fugazzola[@]auxologico.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 10, 2025
• Est. primary completion date: January 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

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

Country	Name	City	State
Italy	Istituto Auxologico Italiano IRCCS	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thyroid nodule volume reduction rate	The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline	1 month after the procedure
Primary	Thyroid nodule volume reduction rate	The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline	6 months after the procedure
Primary	Thyroid nodule volume reduction rate	The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline	12 months after the procedure
Primary	Complication rate	Assessment of the complications of the procedure and over time	When the procedure is performed
Primary	Complication rate	Assessment of the complications of the procedure and over time	1 month after the procedure
Primary	Complication rate	Assessment of the complications of the procedure and over time	6 months after the procedure
Primary	Complication rate	Assessment of the complications of the procedure and over time	12 months after the procedure