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Trial Title:
Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation
NCT ID:
NCT05765695
Condition:
Thyroid Nodule
Conditions: Official terms:
Thyroid Nodule
Thyroid Diseases
Conditions: Keywords:
thyroid nodule
indeterminate
genetic
radiofrequency ablation
follow-up
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Radiofrequency ablation performed with a 19 gauge STARmed needle.
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.
Arm group label:
Treated group
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.
Criteria for 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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Istituto Auxologico Italiano IRCCS
Address:
City:
Milan
Zip:
20149
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Laura Fugazzola
Phone:
+390261911
Phone ext:
2727
Email:
l.fugazzola@auxologico.it
Start date:
January 10, 2021
Completion date:
January 10, 2025
Lead sponsor:
Agency:
Istituto Auxologico Italiano
Agency class:
Other
Source:
Istituto Auxologico Italiano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05765695
