Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation

April 15, 2024 updated by: Istituto Auxologico Italiano

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20149
        • Recruiting
        • Istituto Auxologico Italiano IRCCS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2021

Primary Completion (Estimated)

January 10, 2025

Study Completion (Estimated)

January 10, 2025

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05C023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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