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

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Nodule
• Intervention / Treatment: Device: Laser ablation of benign thyroid nodule

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Mercy Clinic Endocrinology - Smith Glynn Callaway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; Patients will receive laser treatment for benign symptomatic nodules	Device: Laser ablation of benign thyroid nodule; Ablating symptomatic benign thyroid nodules using laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation	Percentage change from baseline volume will be calculated at 3, 6 and 12 months after laser treatment.	12 months
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	Number of patients who develops hypo or hyperthyroidism 3,6 and 12 months after laser treatment.	12 months
Change in Doppler Grade at 3, 6, and 12 Months After Laser Ablation	Number of patients who had changes in blood flow inside the thyroid nodule as evidenced by change in Doppler grade.	12 months
Change in Thyroid Antibody Levels 3,6 and 12 Months After Laser Ablation	Number of patients who develops new thyroid antibodies 3,6, and 12 months after laser ablation	12 months
Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale	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.	3 months, 6 months, and 12 months after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reported Pain Score on the Numerical Scale 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.	Immediately post-procedure
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.	Participants will be asked to answer the following questionnaire after the procedure. How likely is it that you would have the laser ablation procedure again? 1 = Very Likely 2 = Somewhat Likely 3 = Not Likely	Post-procedure on the day of procedure
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0	Treatment related adverse events will be captured using CTCAE v4,0 format	1 year
Reported Pain Score on the Numerical Scale 3 Months 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.	3 months
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.	Participants will be asked to answer the following questionnaire after the procedure. How satisfied were you with the length of the laser ablation procedure? 1= Satisfied 2 = Neither 3 = Dissatisfied	Post-procedure on day of procedure
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the 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	Post-procedure on day of procedure

Collaborators and Investigators

• Sponsor: Johnson Thomas
• Collaborators: Mercy Research
• Investigators: Principal Investigator: Johnson Thomas, MD, FACE, Mercy Research

Publications and helpful links

General Publications

• Pacella CM, Mauri G, Achille G, Barbaro D, Bizzarri G, De Feo P, Di Stasio E, Esposito R, Gambelunghe G, Misischi I, Raggiunti B, Rago T, Patelli GL, D'Este S, Vitti P, Papini E. Outcomes and Risk Factors for Complications of Laser Ablation for Thyroid Nodules: A Multicenter Study on 1531 Patients. J Clin Endocrinol Metab. 2015 Oct;100(10):3903-10. doi: 10.1210/jc.2015-1964. Epub 2015 Aug 14.
• Papini E, Rago T, Gambelunghe G, Valcavi R, Bizzarri G, Vitti P, De Feo P, Riganti F, Misischi I, Di Stasio E, Pacella CM. Long-term efficacy of ultrasound-guided laser ablation for benign solid thyroid nodules. Results of a three-year multicenter prospective randomized trial. J Clin Endocrinol Metab. 2014 Oct;99(10):3653-9. doi: 10.1210/jc.2014-1826. Epub 2014 Jul 22.
• Pacella CM, Mauri G, Cesareo R, Paqualini V, Cianni R, De Feo P, Gambelunghe G, Raggiunti B, Tina D, Deandrea M, Limone PP, Mormile A, Giusti M, Oddo S, Achille G, Di Stasio E, Misischi I, Papini E. A comparison of laser with radiofrequency ablation for the treatment of benign thyroid nodules: a propensity score matching analysis. Int J Hyperthermia. 2017 Dec;33(8):911-919. doi: 10.1080/02656736.2017.1332395. Epub 2017 Jun 12.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): September 28, 2023

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Benign thyroid nodule
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: 18-113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes