Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation
NCT ID: NCT05765695
Last Updated: 2024-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2021-01-10
2025-01-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treated group
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with contraindications to radiofrequency ablation
* Patients with cytology different from TIR3A
* Patients with positive genetic test for mutations associated with thyroid carcinoma
ALL
No
Sponsors
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Istituto Auxologico Italiano
OTHER
Responsible Party
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Locations
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Istituto Auxologico Italiano IRCCS
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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05C023
Identifier Type: -
Identifier Source: org_study_id
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