Laser Ablation of Papillary Thyroid Microcarcinoma

Phase 2

Active, not recruiting

• Conditions: Thyroid Cancer; Papillary Thyroid Microcarcinoma; Thyroid
• Interventions: Procedure: Percutaneous Laser Ablation (PLA)

• Registration Number: NCT04623801
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-19
• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-10
• Status Verified: 2024-09
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with papillary microcarcinoma (PTMC)	Percutaneous Laser Ablation (PLA)	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with complete thermal ablation	6 months	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States