Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses - Full Text View

Sponsor:	BioTex, Inc.
Collaborator:	Rhode Island Hospital
Information provided by:	BioTex, Inc.
ClinicalTrials.gov Identifier:	NCT00615537

Purpose

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	Intervention
Thyroid Nodule Thyroid Cancer Thyroid Neoplasms Nodular Goiter	Procedure: Laser Ablation of Thyroid Nodule

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses

Resource links provided by NLM:

MedlinePlus related topics: Cancer Thyroid Cancer Thyroid Diseases

U.S. FDA Resources

Further study details as provided by BioTex, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2008
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615537

Locations

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

Investigators

Principal Investigator:

Damian Dupuy, MD

Rhode Island Hospital

More Information

Additional Information:

Background on Laser Interstitial Thermal Therapy This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ashok Gowda, Ph.D. President, BioTex, Inc.
ClinicalTrials.gov Identifier:	NCT00615537 History of Changes
Other Study ID Numbers:	BTX-07-003
Study First Received:	February 3, 2008
Last Updated:	April 4, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by BioTex, Inc.:

Thyroid Nodule
Thyroid Cancer
Laser Ablation

LITT
Nodular Goiter
Thyroid Mass

Additional relevant MeSH terms:

Neoplasms
Thyroid Neoplasms
Goiter
Goiter, Nodular
Thyroid Diseases

Thyroid Nodule
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 24, 2012