Laser Ablation of Papillary Thyroid Microcarcinoma
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT04623801
This study evaluates the safety and efficacy of percutaneous laser ablation (PLA) for papillary thyroid microcarcinoma. Eligible participants are adults with specific cytological and ultrasonographic criteria, a maximum lesion diameter of 13 mm, and no evidence of metastasis. PLA involves a single session using a 21-gauge needle under ultrasound guidance.
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Program Overview
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.
Eligibility Criteria
Inclusion Criteria
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Age ≥ 18 years
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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
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