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Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation

Primary Purpose

Thyroid Nodule

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Radiofrequency ablation performed with a 19 gauge STARmed needle.
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Nodule focused on measuring thyroid nodule, indeterminate, genetic, radiofrequency ablation, follow-up

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Istituto Auxologico Italiano IRCCSRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treated group

Arm Description

Outcomes

Primary Outcome Measures

Thyroid nodule volume reduction rate
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Thyroid nodule volume reduction rate
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Thyroid nodule volume reduction rate
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Complication rate
Assessment of the complications of the procedure and over time
Complication rate
Assessment of the complications of the procedure and over time
Complication rate
Assessment of the complications of the procedure and over time
Complication rate
Assessment of the complications of the procedure and over time

Secondary Outcome Measures

Full Information

First Posted
February 27, 2023
Last Updated
March 9, 2023
Sponsor
Istituto Auxologico Italiano
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1. Study Identification

Unique Protocol Identification Number
NCT05765695
Brief Title
Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation
Official Title
Radiofrequency Ablation for Treating Thyroid Nodules Classified as TIR3A, With a Negative Genetic Evaluation for Thyroid Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
January 10, 2024 (Anticipated)
Study Completion Date
January 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule
Keywords
thyroid nodule, indeterminate, genetic, radiofrequency ablation, follow-up

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treated group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation performed with a 19 gauge STARmed needle.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Thyroid nodule volume reduction rate
Description
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Time Frame
1 month after the procedure
Title
Thyroid nodule volume reduction rate
Description
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Time Frame
6 months after the procedure
Title
Thyroid nodule volume reduction rate
Description
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Time Frame
12 months after the procedure
Title
Complication rate
Description
Assessment of the complications of the procedure and over time
Time Frame
When the procedure is performed
Title
Complication rate
Description
Assessment of the complications of the procedure and over time
Time Frame
1 month after the procedure
Title
Complication rate
Description
Assessment of the complications of the procedure and over time
Time Frame
6 months after the procedure
Title
Complication rate
Description
Assessment of the complications of the procedure and over time
Time Frame
12 months after the procedure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Fugazzola
Phone
+390261911
Ext
2727
Email
l.fugazzola@auxologico.it
Facility Information:
Facility Name
Istituto Auxologico Italiano IRCCS
City
Milan
ZIP/Postal Code
20149
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Fugazzola
Phone
+390261911
Ext
2727
Email
l.fugazzola@auxologico.it

12. IPD Sharing Statement

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Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation

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