Laser Ablation of Papillary Thyroid Microcarcinoma

Phase 2

Active, not recruiting

• Conditions: Thyroid Cancer; Papillary Thyroid Microcarcinoma; Thyroid

• 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

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