Laser Ablation of Papillary Thyroid Microcarcinoma
Pilot Study to Evaluate the Safety and Efficacy of Percutaneous Laser Ablation of Thyroid Papillary Microcarcinoma
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2020
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2020
CompletedFirst Submitted
Initial submission to the registry
November 6, 2020
CompletedFirst Posted
Study publicly available on registry
November 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
October 8, 2025
October 1, 2025
6 years
November 6, 2020
October 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Participants with papillary microcarcinoma (PTMC)
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
R. Michael Tuttle, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2020
First Posted
November 10, 2020
Study Start
October 19, 2020
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
October 8, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
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.