Laser Ablation of Papillary Thyroid Microcarcinoma

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Papillary Thyroid Microcarcinoma; Thyroid; Thyroid Cancer

Treatments: Procedure: Percutaneous Laser Ablation (PLA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04623801

19-438

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Participants with papillary microcarcinoma (PTMC)

Experimental group

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.

Treatment:

Procedure: Percutaneous Laser Ablation (PLA)