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Laser Ablation of Papillary Thyroid Microcarcinoma

Primary Purpose

Papillary Thyroid Microcarcinoma, Thyroid, Thyroid Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Percutaneous Laser Ablation (PLA)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papillary Thyroid Microcarcinoma focused on measuring PTMC, Papillary Thyroid Microcarcinoma, Thyroid Cancer, Percutaneous Laser Ablation, PLA, 19-438, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with papillary microcarcinoma (PTMC)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2020
Last Updated
July 14, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04623801
Brief Title
Laser Ablation of Papillary Thyroid Microcarcinoma
Official Title
Pilot Study to Evaluate the Safety and Efficacy of Percutaneous Laser Ablation of Thyroid Papillary Microcarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Thyroid Microcarcinoma, Thyroid, Thyroid Cancer
Keywords
PTMC, Papillary Thyroid Microcarcinoma, Thyroid Cancer, Percutaneous Laser Ablation, PLA, 19-438, Memorial Sloan Kettering Cancer Center

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with papillary microcarcinoma (PTMC)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Laser Ablation (PLA)
Intervention Description
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 Outcome Measure Information:
Title
Number of participants with complete thermal ablation
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
R. Michael Tuttle, MD
Phone
646-608-3910
Email
tuttler@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Solomon, MD
Phone
212-639-5012
Email
solomons@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Michael Tuttle, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R. Michael Tuttle, MD
Phone
646-608-3910

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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Laser Ablation of Papillary Thyroid Microcarcinoma

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