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

Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04277455
• Other study ID #: 18-113
• Status: Completed
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: September 28, 2023

Study information

• Verified date: May 2024
• Source: Mercy Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 28, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

Device:
• Laser ablation of benign thyroid nodule
Ablating symptomatic benign thyroid nodules using laser

Locations

Country	Name	City	State
United States	Mercy Clinic Endocrinology - Smith Glynn Callaway	Springfield	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Johnson Thomas	Mercy Research

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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