Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules

Not Applicable

Completed

Conditions: Thyroid Nodule

Interventions: Device: Laser ablation of benign thyroid nodule

Registration Number: NCT04277455

Lead Sponsor: Johnson Thomas

Brief Summary: This is a prospective trial to evaluate the effects of laser ablation on symptomatic benign thyroid nodules. The study is designed to assess the clinical efficacy, safety, tolerability and impact on symptoms of single ultrasound guided laser ablation treatment of symptomatic benign thyroid nodules. Approximately 20 subjects will undergo laser ablation of symptomatic benign nodules.

Detailed Description: * Laser ablation will be carried out in a single session under sterile conditions and ultrasound guidance with the support of Echolaser Smart Interface.

* Local anesthesia will be offered.

* The treatment plan will be assisted using the Echolaser Smart Interface.

* Depending on the shape and volume of the nodule to be treated, the investigator will determine whether one or two needles positioned parallel to each other along the longitudinal axis of the nodule will need to be used for treatment.

* Under ultrasound guidance, the investigator will introduce up to two 21-gauge introducer needles through the Guide kit into the target thyroid lesion percutaneously.

* Once the correct positioning of the needles has been verified under ultrasound imaging, an optical fiber is introduced into each needle with its tip protruding 5 mm out of the needle and in direct contact with the tissue to be ablated.

* Laser beam emission through the flat-tipped optical fiber produces a lesion (coagulation volume) within the nodule of an ellipsoidal shape, one third of which is positioned behind the tip of the fiber, and two-thirds in front.

* Each application session will last between 400 and 600 seconds under a laser source power output of 3W. An application is defined as the time between turning on and turning off the laser source.

* Up to 3 applications may be carried out during the same treatment session by pulling back along the needle and fiber axis by 0.5-1.0-1.5 cm to allow for treatment of tissue area not treated with previous application.

* Following completion of the laser ablation, the fibers will be removed followed by extraction of the needle(s). Hemostasis will be achieved at the site of needle insertion by applying pressure to the site.

* External bleeding will be assessed by visual inspection following extraction of the needle.

* Internal bleeding and potential nodule rupture will be assessed by ultrasound of the thyroid/neck with doppler flow assessment by the investigator following needle extraction using GE Logiq P6 ultrasound.The site will be covered with a sterile dressing/bandage.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

Inclusion Criteria

Males or females, Age ≥18 years
Thyroid Stimulating Hormone (TSH) within normal limits
Presence of thyroid nodule >29 mm and ≤60 mm in the longest dimension on ultrasound imaging
Symptoms from thyroid nodule - tightness or pressure in neck, neck tenderness, neck pain, difficulty swallowing, voice changes, shortness of breath or cosmetic disfigurement
Solid thyroid nodule with less than 20% cystic component
Cytological benign nodule proven by previous biopsy within 2 years
Ability to place the laser tip inside the nodule and to keep vital structures (i.e. trachea and esophagus) outside the zone of injury. To achieve this safe zone, we will leave a minimum of 17 mm distance between the fiber tip anterior to the vital structures and 10 mm from the fiber tip in all other dimensions.
Not on anticoagulants or anticoagulants stopped for appropriate amount of time based on the pharmacology of the drug
Ability to understand and willingness to provide informed consent

Exclusion Criteria

Pregnancy
Diagnosis of Hyperthyroidism
Malignant thyroid nodule
Egg shell or coarse calcification in the thyroid nodule
Patient on anticoagulation which cannot be stopped due to medical reasons
Coagulopathy
Thyroid nodules in contact with trachea, esophagus or major blood vessels
Prior neck surgery
Prior radiation to head and neck
Previous radioactive iodine treatment
Current iodine supplementation
Current anti-thyroid medication
Biotin supplementation within 2 days prior to enrollment
Allergy to Ethyl chloride spray or lidocaine
Physical and psychological conditions that prevent safe administration of the procedure as determined by the investigator
Adults not able to consent
Prisoners
Individuals who cannot read and understand English

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	Laser ablation of benign thyroid nodule	Patients will receive laser treatment for benign symptomatic nodules

Primary Outcome Measures

Name	Time	Method
Change in Thyroid Antibody Levels 3,6 and 12 Months After Laser Ablation	12 months	Number of patients who develops new thyroid antibodies 3,6, and 12 months after laser ablation
Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation	12 months	Percentage change from baseline volume will be calculated at 3, 6 and 12 months after laser treatment.
Change in Doppler Grade at 3, 6, and 12 Months After Laser Ablation	12 months	Number of patients who had changes in blood flow inside the thyroid nodule as evidenced by change in Doppler grade.
Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale	3 months, 6 months, and 12 months after procedure	Patients perceived cosmetic appearance will be measured using a numerical scale at baseline, immediately after procedure and then at 3, 6 and 12 months after procedure using following question. On a scale from 0 to 10, how much does your thyroid nodule affect your appearance? 0 being the best outcome and 10 being the worst outcome.
Change in the Thyroid Function After Laser Treatment Assessed by the Measurement of TSH and Free T4 at 3, 6 and 12 Months After Laser Ablation	12 months	Number of patients who develops hypo or hyperthyroidism 3,6 and 12 months after laser treatment.

Secondary Outcome Measures

Name	Time	Method
Reported Pain Score on the Numerical Scale 3 Months Post Procedure.	3 months	Change in pain will be measured using a numerical scale at baseline, immediately post procedure and 3 months after procedure using the following question. Rate your pain on a scale from 0 to 10 where 0 is no pain and 10 is the worst pain possible.
Reported Pain Score on the Numerical Scale Immediately Post Procedure.	Immediately post-procedure	Change in pain will be measured using a numerical scale at baseline, immediately post procedure and 3 months after procedure using the following question. Rate your pain on a scale from 0 to 10 where 0 is no pain and 10 is the worst pain possible.
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.	Post-procedure on day of procedure	Participants will be asked to answer the following questionnaire after the procedure. How much discomfort did you have with the laser ablation procedure? 1= Less than I thought 2 = About what I thought 3 = More than I thought
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0	1 year	Treatment related adverse events will be captured using CTCAE v4,0 format