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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with papillary microcarcinoma (PTMC) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Age ≥ 18 years
Papillary thyroid cancer documented by
To ensure the majority of cases will be eligible based on criteria (a) or (b), we will enroll ≤ 2 patients based on criteria (c).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R. Michael Tuttle, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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| ID | Term |
|---|---|
| C563277 | Papillary Thyroid Microcarcinoma |
| D013959 | Thyroid Diseases |
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D006258 |
| Head and Neck Neoplasms |