Laser Ablation of Papillary Thyroid Microcarcinoma

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

Study Overview

• Status: Recruiting
• Conditions: Thyroid; Thyroid Cancer; Papillary Thyroid Microcarcinoma
• Intervention / Treatment: Procedure: Percutaneous Laser Ablation (PLA)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: R. Michael Tuttle, MD; Phone Number: 646-608-3910; Email: tuttler@mskcc.org
• Study Contact Backup: Name: Stephen Solomon, MD; Phone Number: 212-639-5012; Email: solomons@mskcc.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: R. Michael Tuttle, MD; Phone Number: 646-608-3910

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants with papillary microcarcinoma (PTMC); 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); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: R. Michael Tuttle, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; Papillary Thyroid Microcarcinoma; Thyroid Cancer; PTMC; Percutaneous Laser Ablation; PLA; 19-438
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Thyroid Diseases; Thyroid Neoplasms; Carcinoma, Papillary
• Other Study ID Numbers: 19-438

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes