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

NCT04277455 | Completed Results DMC FDA Device

• 1 other identifier: 18-113
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Nodule

Keywords

Benign thyroid nodule

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Reported Pain Score on the Numerical Scale Immediately Post Procedure.

  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.

  Post-procedure on the day of procedure

• Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0

  1 year

• Reported Pain Score on the Numerical Scale 3 Months Post Procedure.

  3 months

• 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

Study Arms (1)

Treatment arm

EXPERIMENTAL

Patients will receive laser treatment for benign symptomatic nodules

Device: Laser ablation of benign thyroid nodule

Interventions

Laser ablation of benign thyroid nodule DEVICE

Ablating symptomatic benign thyroid nodules using laser

Treatment arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson Thomas: lead
• Mercy Research: collaborator

Study Sites (1)

Mercy Clinic Endocrinology - Smith Glynn Callaway

Springfield, Missouri, 65807, United States

Location

Related 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.

  PMID: 26274342 BACKGROUND

• 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.

  PMID: 25050903 BACKGROUND

• 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.

  PMID: 28605944 BACKGROUND

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Limitations and Caveats

There are a few limitations to this study. This is a single-center study with a small sample size, which makes findings less generalizable. Pain, tolerability, and cosmetic assessments are subjective and hard to quantify objectively. Hence, we used standardized scales to reduce subjectivity. There was also no control group. Longterm outcomes were not assessed because subjects were only followed for 12 months after the laser ablation procedure.

Results Point of Contact

• Title: Dr. Johnson Thomas
• Organization: Mercy Research

johnson.thomas@mercy.net

417-888-5660

Study Officials

• Johnson Thomas, MD, FACE

  Mercy Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 20, 2020
• Study Start: October 26, 2020
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: June 3, 2024
• Results First Posted: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)