Study Results
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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ACTIVE_NOT_RECRUITING
PHASE2
10 participants
INTERVENTIONAL
2020-10-19
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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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
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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19-438
Identifier Type: -
Identifier Source: org_study_id
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