Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses
Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses
This proposal is designed as a pilot study for the use of laser ablation for local control of
 symptomatic (e.g compressive) benign thyroid masses in 20 patients.
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 by
 US.

 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.
Inclusion Criteria:

 -  Histologically or cytologically documented benign thyroid nodule, or cold thyroid
 nodule as documented by thyroid scan.

 -  Patient has been evaluated by endocrinology and endocrine surgery and has been deemed
 suitable candidate for procedure.

 -  The patient's nodule(s) size and number must be no larger than 5cm and a maximum of 3
 nodules, respectively.

 -  All nodules must be greater than 1cm from the expected location of the recurrent
 laryngeal and vagus nerves determined under ultrasound.

 -  Required initial laboratory values: T3, T4. TSH, and Thyroglobulin (for treated
 metastatic lymph nodes)

 -  All patients must understand and sign a study-specific informed consent.

 Exclusion Criteria:

 -  Thyroid mass in contact with trachea or esophagus.

 -  Uncontrolled coagulopathy or bleeding diathesis that cannot be corrected with FFP and
 platelets prior to procedure. (Platelets must be ≥ 70,000/ul.)

 -  Aspirin and nonsteroidal anti-inflammatory medications, antiplatelet medications, or
 warfarin must be discontinued prior to the procedure for a time period that is
 appropriate given the drug half-life and the drugs known antiplatelet activity (e.g.
 aspirin for 7 days and ibuprofen 24 hours). Low molecular weight heparin preparations
 must be discontinued 24 hours prior to procedure.