Laser Ablation for the Treatment of Papillary Thyroid Microcarcinoma

PRIMARY OBJECTIVE:

I. Complete thermal ablation of the targeted PTMC (T1aN0M0) lesion as determined by examination of thyroid tissue obtained by either thyroid lobectomy, total thyroidectomy, or double fine needle aspiration cytology 6 +/- 2 months after PLA.

SECONDARY OBJECTIVES:

I. To describe the impact of PLA on the technical aspects of thyroidectomy (such as alterations in tissue planes or fibrotic changes) evident at the time of thyroid surgery.

II. To describe thermal damage to surrounding vascular, airway, or nervous structures based on intra-operative findings and histological examination of the thyroid specimen.

III. To describe changes in ultrasonographic characteristics of the PTMC at 3 and 6 months after PLA.

IV. To describe how often the 6-month post PLA ultrasound shows complete resolution of the ablation zone as defined by having no ultrasonographic evidence of the PTMC or residual scar tissue (i.e., only normal appearing thyroid tissue by ultrasound at the site of previous PLA).

OUTLINE:

Patients undergo PLA using the EchoLaser Evo System. At 3 and 6 months after PLA, patients undergo a neck ultrasound examination to check disease status. If the ultrasounds show evidence of cancer or scar tissue, patients undergo standard of care surgery to remove half (lobectomy) or all of the thyroid gland (total thyroidectomy) for microscopic examination or two fine needle aspiration (FNA) biopsies (done at least 1 week apart) to conclusively determine whether the PLA procedure was able to completely destroy the cancer cells. If the 6-month neck ultrasound shows only normal tissue, patients may choose to forgo standard thyroid surgery or FNA biopsy confirmation.