Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00615537
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : April 5, 2011
Rhode Island Hospital
Information provided by:
BioTex, Inc.

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.

Condition or disease Intervention/treatment Phase
Thyroid Nodule Thyroid Cancer Thyroid Neoplasms Nodular Goiter Procedure: Laser Ablation of Thyroid Nodule Not Applicable

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), 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses
Study Start Date : February 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid
U.S. FDA Resources

Intervention Details:
    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.
    Other Names:
    • PhoTex15 Diode Laser
    • Visualase Cooled Laser Applictor System

Primary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00615537

United States, Rhode Island
Rhode Island Hospital - Department of Diagnostic Imaging Research
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
BioTex, Inc.
Rhode Island Hospital
Principal Investigator: Damian Dupuy, MD Rhode Island Hospital

Responsible Party: Ashok Gowda, Ph.D. President, BioTex, Inc. Identifier: NCT00615537     History of Changes
Other Study ID Numbers: BTX-07-003
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: April 5, 2011
Last Verified: April 2011

Keywords provided by BioTex, Inc.:
Thyroid Nodule
Thyroid Cancer
Laser Ablation
Nodular Goiter
Thyroid Mass

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Thyroid Nodule
Goiter, Nodular
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms