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OpenTrials
Active, Not Recruiting

NCT Number: NCT04623801

Laser Ablation of Papillary Thyroid Microcarcinoma

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Papillary Thyroid Microcarcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Thyroid Cancer Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Laser Ablation (PLA)

Procedure

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.

Primary outcomes

  1. Number of participants with complete thermal ablation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Nov 10, 2020
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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