Laser Ablation of Papillary Thyroid Microcarcinoma

Study Overview
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Brief Summary
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The purpose of this study is to explore whether percutaneous laser ablation (PLA) is a safe and effective alternative to removing papillary thyroid microcarcinoma (PTMC) with surgery.

Official Title
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Pilot Study to Evaluate the Safety and Efficacy of Percutaneous Laser Ablation of Thyroid Papillary Microcarcinoma

Conditions
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Papillary Thyroid Microcarcinoma, Thyroid, Thyroid Cancer

Intervention / Treatment
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* Procedure: Percutaneous Laser Ablation (PLA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Papillary thyroid cancer documented by (a) Bethesda VI cytology, (b) Bethesda III, IV, V, or VI cytology AND BRAF V600E mutation, or (c) Bethesda V cytology AND high risk ultrasonographic features documented by either the ATA high suspicion or TIRADS 5 nodule characteristics To ensure the majority of cases will be eligible based on criteria (a) or (b), we will enroll ≤ 2 patients based on criteria (c). Maximum diameter ≤ 13 mm Declined active surveillance The thyroid lesion must be primarily solid with ≤ 25% cystic compent No US evidence of extrathyroidal extension through the thyroid capsule No imaging evidence of lymph node metastasis Preserved contralateral vocal cord function prior to PLA Exclusion Criteria: Thyroid cancer that is non papillary thyroid cancer (PTC) Thyroid lesion with > 25% cystic component Lesion with US evidence of extrathyroidal extension through the thyroid capsule Clinical or ultrasonographic evidence of lymph node metastasis Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with papillary microcarcinoma (PTMC)<br>Participants with papillary microcarcinoma (PTMC) who have elected to proceed with thyroidectomy rather than an observational management approach will be considered as potential candidates for this trial. | Procedure: Percutaneous Laser Ablation (PLA)<br>* Percutaneous Laser Ablation / PLA will be carried out in a single session by advancing one 21-gauge spinal needle into the target lesions under real time US guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with complete thermal ablation | Complete thermal ablation of the targeted PTMC (T1aN0M0) as determined by histological examination of thyroid tissue obtained by either thyroid lobectomy or total thyroidectomy 6 months after PLA. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PLA, PTMC, Papillary Thyroid Microcarcinoma, Thyroid Cancer, Percutaneous Laser Ablation, 19-438, Memorial Sloan Kettering Cancer Center