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Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses

Primary Purpose

Thyroid Nodule, Thyroid Cancer, Thyroid Neoplasms

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Laser Ablation of Thyroid Nodule

About this trial

This is an interventional treatment trial for Thyroid Nodule focused on measuring Thyroid Nodule, Thyroid Cancer, Laser Ablation, LITT, Nodular Goiter, Thyroid Mass

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rhode Island Hospital - Department of Diagnostic Imaging Research

Outcomes

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.

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.

Full Information

NCT ID

NCT00615537

First Posted

February 3, 2008

Last Updated

April 4, 2011

Sponsor

BioTex, Inc.

Collaborators

Rhode Island Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00615537

Brief Title

Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses

Official Title

Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

BioTex, Inc.

Collaborators

Rhode Island Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Nodule, Thyroid Cancer, Thyroid Neoplasms, Nodular Goiter

Keywords

Thyroid Nodule, Thyroid Cancer, Laser Ablation, LITT, Nodular Goiter, Thyroid Mass

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Laser Ablation of Thyroid Nodule

Other Intervention Name(s)

PhoTex15 Diode Laser, Visualase Cooled Laser Applictor System

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Damian Dupuy, MD

Organizational Affiliation

Rhode Island Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rhode Island Hospital - Department of Diagnostic Imaging Research

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

12. IPD Sharing Statement

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Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses

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