Laser Ablation of Papillary Thyroid Microcarcinoma

NCT ID: NCT04623801

Last Updated: 2025-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2026-10-31

Brief Summary

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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

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Conditions

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Papillary Thyroid Microcarcinoma Thyroid Thyroid Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Percutaneous Laser Ablation (PLA)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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R. Michael Tuttle, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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19-438

Identifier Type: -

Identifier Source: org_study_id

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