HIFU Treatment of Benign Thyroid Nodules

Launched by THERACLION · Jan 15, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called high intensity focused ultrasound (HIFU) for benign thyroid nodules, which are non-cancerous lumps in the thyroid gland. The goal is to see how effective and safe this treatment is for patients who experience symptoms like difficulty swallowing or discomfort due to these nodules. The trial is not yet recruiting participants, but when it begins, it will be looking for adults between 18 and 70 years old who have a specific type of thyroid nodule that meets certain size and imaging criteria.

To participate, individuals must not have had radiation to the neck, must have normal thyroid function, and should not have any other major health issues, like certain heart or lung diseases. Participants will likely experience an outpatient procedure with HIFU, which aims to reduce the size of their thyroid nodules without surgery. It's important for potential participants to know that they will need to provide written consent and that they should not be pregnant or breastfeeding. If you're interested in this treatment, speak with your doctor to see if you might qualify when recruitment begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients older than 18 years and younger than 70 years
• • 2. No history of neck irradiation
• • 3. Normal thyroid function, serum calcitonin level, PTH and serum calcium at screening visit examination.
• • 4. No abnormal cervical lymph nodes during screening visit examination.
• 5. The target thyroid nodule must meet all of the following conditions:
• • 1. Single nodule, 2cm≤max diameter≤4cm
• • 2. Causing appearance , pressure or swallowing symptoms
• • 3. Composition of target nodule: solid or predominantly solid (solid area≥80%)
• • 4. Ultrasound imaging of target nodule assessed by 2017 ACR TI-RADS(≤Grade 3), and proved benign by once FNA (bethesda categoryⅡ); Ultrasound imaging of target nodule assessed by 2017 ACR TI-RADS( Grade 4), and proved benign by twice FNA (bethesda categoryⅡ).
• • 5. The distance from the posterior edge of the target nodule to the skin is not less than 12.3mm, and the depth from the anterior edge of the target nodule to the skin is not more than 19.4mm.
• • 6. No macro-calcifications in target nodule, macro-calcifications induce a significant shadow in the ultrsound imaging.
• • 7. the skin is free from any significant thick scars.
• 6. If there are more than one nodule on the treatment side, all of the following conditions shall be met:
• • 1. No more than 2 nodules except the target nodule.
• • 2. Maximum diameter of the nodules is smaller than 1 cm and ultrasound imaging ≤ Grade 3 assessed by 2017 ACR TI-RADS.
• 7. If there are nodules on the opposite side of HIFU treatment side, one of the following conditions shall be met:
• • 1. Maximum diameter of these nodules is smaller than 1 cm and ultrasound imaging ≤ Grade 3 assessed by 2017 ACR TI-RADS.
• • 2. Only one nodule with 1cm≤ max diameter \< 2cm, or/and no more than three nodule with max diameter \<1cm. Ultrasonic images of all nodules≤Grade 3 assessed by 2017 ACR TI-RADS.
• • 8. Absence of abnormal vocal cord mobility at laryngoscopy.
• • 9. Patients reject or cannot tolerate invasive surgical treatment.
• • 10. Patient has signed a written informed consent.
• Exclusion Criteria:
• • 1. The ultrasound report indicated that follicular tumors were not excluded.
• • 2. Known history of thyroid cancer or other neoplasias in the neck region.
• • 3. Head and/or neck disease that prevents hyper-extension of neck.
• • 4. Patients currently in the acute phase of any disease.
• • 5. History of head and neck, pulmonary and systemic infections in the last 2 weeks.
• • 6. The white blood cell test result exceeded the upper limit of the normal range.
• • 7. Tenderness of the thyroid and/or thyroid nodules.
• • 8. History of arrhythmia, coronary heart disease or valvular heart disease, heart failure.
• • 9. The blood pressure is not controlled after the combination of three antihypertensive drugs (SBP ≥ 140 mmHg, DBP ≥ 90 mmHg)
• • 10. COPD history or acute phase of asthma attach
• • 11. Patients with liver dysfunction ( ALT or AST level 2.5 times higher than the upper limit of the normal reference range)
• • 12. Patients with renal insufficiency( eGFR\< 45ml/min/1.73m2).
• • 13. Fasting blood glucose \>8mmol/L after hypoglycemic drug treatment
• • 14. Patients currently sufferrign from hematological diseases or bleeding tendency, or patients currently requiring continuous administration of antiplatelet and anticoagulant drugs
• • 15. Pregnant or lactating woman
• • 16. Woman who Plan to be pregnant during the study period.
• • 17. Any contraindication to the assigned analgesia/ anaesthesia.
• • 18. Patients who participated in other clinical trials in the past 3 months.
• • 19. Alzhemier's patients or patient with cognitive impairment.
• • 20. Other patients judged by the investigators to be unsuitable for the clinical trial.