Clinical trial · Interventional
Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation
Radiofrequency Ablation for Treating Thyroid Nodules Classified as TIR3A, With a Negative Genetic Evaluation for Thyroid Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation performed with a 19 gauge STARmed needle. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treated group
- interventionNames
- Procedure: Radiofrequency ablation performed with a 19 gauge STARmed needle.
Primary outcomes (7)
- measure
- Thyroid nodule volume reduction rate
- timeFrame
- 1 month after the procedure
- description
- The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
- measure
- Thyroid nodule volume reduction rate
- timeFrame
- 6 months after the procedure
- description
- The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available