Status:
COMPLETED
Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses
Lead Sponsor:
BioTex, Inc.
Collaborating Sponsors:
Rhode Island Hospital
Conditions:
Thyroid Nodule
Thyroid Cancer
Eligibility:
All Genders
Phase:
NA
Brief Summary
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.
Detailed Description
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), cl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00615537
Start Date
February 1 2008
End Date
January 1 2011
Last Update
April 5 2011
Active Locations (1)
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1
Rhode Island Hospital - Department of Diagnostic Imaging Research
Providence, Rhode Island, United States, 02903