Clinical trial NCT04277455: Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules
Official title: Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Nodule
Keywords: Benign thyroid nodule
Lead sponsor: Mercy Research
Sponsor class: OTHER
Collaborators: name: Mercy Research
First posted: 2020-02-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: Change in Doppler Grade at 3, 6, and 12 Months After Laser Ablation
timeFrame: 12 months
measure: Change in Thyroid Antibody Levels 3,6 and 12 Months After Laser Ablation
timeFrame: 12 months
measure: Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale
timeFrame: 3 months, 6 months, and 12 months after procedure
Secondary outcomes:
measure: Reported Pain Score on the Numerical Scale Immediately Post Procedure.
timeFrame: Immediately post-procedure
measure: Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
timeFrame: Post-procedure on the day of procedure
measure: Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: 1 year
measure: Reported Pain Score on the Numerical Scale 3 Months Post Procedure.
timeFrame: 3 months
measure: Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
timeFrame: Post-procedure on day of procedure
measure: Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
timeFrame: Post-procedure on day of procedure
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Mercy Clinic Endocrinology - Smith Glynn Callaway
state: Missouri
Study officials:
affiliation: Mercy Research
name: Johnson Thomas, MD, FACE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.