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

Status Completed

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.

Clinical Trial 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 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

• NCT number: NCT00615537
• Study type: Interventional
• Source: BioTex, Inc.
• Status: Completed
• Phase: N/A
• Start date: February 2008
• Completion date: January 2011