N/A
N=10
Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules
Thyroid Nodule
Bottom Line
View on ClinicalTrials.gov: NCT04277455 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation — 63.4; 71.087 percentage of volume reduction
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laser ablation of benign thyroid nodule (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson Thomas
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation |
63.4; 71.087 | — |
| 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 |
0; 10 | — |
| PRIMARY Change in Doppler Grade at 3, 6, and 12 Months After Laser Ablation |
1; 0; 0 | — |
| PRIMARY Change in Thyroid Antibody Levels 3,6 and 12 Months After Laser Ablation |
0; 10 | — |
| PRIMARY Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale |
3; 0.9; 0.6; .78 | — |
| SECONDARY Reported Pain Score on the Numerical Scale Immediately Post Procedure. |
5.5 | — |
| SECONDARY Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure. |
1; 3; 6 | — |
| SECONDARY Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0 |
1; 1; 1; 1; 1; 2 | — |
| SECONDARY Reported Pain Score on the Numerical Scale 3 Months Post Procedure. |
10; 0 | — |
| SECONDARY Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure. |
1; 3; 6 | — |
| SECONDARY Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure. |
1; 3; 6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04277455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.