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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05765695
Other study ID # 05C023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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