Thyroid Cancer Clinical Trial
Official title:
Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses
Verified date | April 2011 |
Source | BioTex, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Rhode Island Hospital - Department of Diagnostic Imaging Research | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
BioTex, Inc. | Rhode Island Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 months | No | |
Secondary | To assess the effects of laser ablation on thyroid function testing. An estimate of time and cost associated with LITT procedure for treatment of soft tissue thyroid nodules. | 12 months | No |
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