Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses
Thyroid nodules are a very common clinical finding, with an estimated prevalence (based on
palpation) ranging from 3% to 7% among the general population. With the widespread use of
ultrasound (US), clinically unapparent thyroid nodule prevalence has dramatically increased
with estimates at 20% to 76% in the general population. Moreover, 20% to 48% of patients
with a single palpable thyroid nodule are found to have additional nodules when investigated
Laser ablation therapy offer potential for the thermal destruction of soft tissue
structures. The ability to deliver large doses of energy via small flexible fiberoptics
makes laser therapy ideally suited for percutaneous treatment of unwanted tissue masses.
In this study we propose to treat symptomatic soft tissue thyroid masses in the head and
neck region using a new FDA-cleard laser ablation system to safely and effectively debulk
the tissue and therefore improve symptoms. Real time US monitoring will be performed of the
ablation front to ensure complete treatment of the target lesion. All ablated regions will
be followed by US with Doppler to document changes in size and vascularity. Local effects
on thyroid function for thyroid mass treatment will be measured on follow-up.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary goal of this study is to determine the local response of laser ablation of the treated lesion and its effect on size and vascularity. The objective measures will be based on serial US with Doppler.
Damian Dupuy, MD
Rhode Island Hospital
United States: Institutional Review Board
|Rhode Island Hospital - Department of Diagnostic Imaging Research||Providence, Rhode Island 02903|