Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses

Thyroid Cancer Clinical Trial

Official title:

Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615537
• Other study ID #: BTX-07-003
• Status: Completed
• Phase: N/A
• First received: February 3, 2008
• Last updated: April 4, 2011
• Start date: February 2008
• Est. completion date: January 2011

Study information

• Verified date: April 2011
• Source: BioTex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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), 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.

Recruitment information / eligibility

• 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Goiter, Nodular
• Nodular Goiter
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule

Intervention

Procedure:
• Laser Ablation of Thyroid Nodule
Laser ablation using a laser generator, disposable fiberoptic laser fiber, cooling catheter and pump, will be performed under conscious sedation. Ultrasound will be used to localize masses. Local anesthesia will be administered both intradermally and subcutaneously. The laser applicator will be placed into the mass and laser energy will be delivered at 15W for 30-120 seconds. Real-time ultrasound monitoring of the ablation front will be used to ensure complete treatment of the target lesion. In larger masses applicators may be placed of the applicator into multiple locations. The number of locations will be determined by the treatment team, and based on lesion morphology, size, location, and accessibility.

Locations

Country	Name	City	State
United States	Rhode Island Hospital - Department of Diagnostic Imaging Research	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
BioTex, Inc.	Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Cancer Ablation at Rhode Island Hospital
•   Principal Investigator Background