Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses
N/A
N/A
Both
Thyroid Nodule, Thyroid Cancer, Thyroid Neoplasms, Nodular Goiter
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Damian Dupuy, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Rhode Island Hospital
Authority:
United States: Institutional Review Board
Study ID:
BTX-07-003
NCT ID:
NCT00615537
Start Date:
February 2008
Completion Date:
January 2011
Related Keywords:
- Thyroid Nodule
- Thyroid Cancer
- Thyroid Neoplasms
- Nodular Goiter
- Thyroid Nodule
- Thyroid Cancer
- Laser Ablation
- LITT
- Nodular Goiter
- Thyroid Mass
- Neoplasms
- Thyroid Neoplasms
- Goiter
- Goiter, Nodular
- Thyroid Diseases
- Thyroid Nodule
Name | Location |
|---|---|
| Rhode Island Hospital - Department of Diagnostic Imaging Research | Providence, Rhode Island 02903 |
