Laser Ablation of Papillary Thyroid Microcarcinoma

Thyroid Cancer Clinical Trial

Official title:

Pilot Study to Evaluate the Safety and Efficacy of Percutaneous Laser Ablation of Thyroid Papillary Microcarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04623801
• Other study ID #: 19-438
• Status: Recruiting
• Phase: Phase 2
• Start date: October 19, 2020
• Est. completion date: October 2025

Study information

• Verified date: July 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: R. Michael Tuttle, MD
• Phone: 646-608-3910
• Email: tuttler[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Papillary Thyroid Microcarcinoma
• Thyroid
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center