A Multi-center, Randomized, Controlled Trial of High Intensity Focused Ultrasound (HIFU) Treatment of Benign Thyroid Nodules
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thyroid Nodule (Benign)
- Sponsor
- Theraclion
- Enrollment
- 240
- Primary Endpoint
- Effectiveness evaluation using treatment effective rate
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This clinical trial is to evaluate the effectiveness and the safety of high intensity focused ultrasound (HIFU) in the treatment of benign thyroid nodules.
Detailed Description
This clinical trial is a prospective, multicentre, randomized, controlled study of high intensity focused ultrasound (HIFU) treatment of benign thyroid nodules. this study will include 240 patients with benign thyroid nodules that meet all ths the inclusion / exclusion criteria and will be randomly divided into two groups at 1: 1 ratio. Patients in the test group will be treated with high intensity focused ultrasound (HIFU), while patients in the control group will be actively observed and followed up by ultrasound examination. The primary objective of this clinical trial is to evaluate the efficacy of the test device in the treatment of benign thyroid nodules, and the secondary objective is to evaluate the safety of the test device in the treatment of benign thyroid nodules and the improvement of symptoms assessed by VAS score.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients older than 18 years and younger than 70 years
- •No history of neck irradiation
- •Normal thyroid function, serum calcitonin level, PTH and serum calcium at screening visit examination.
- •No abnormal cervical lymph nodes during screening visit examination.
- •The target thyroid nodule must meet all of the following conditions:
- •Single nodule, 2cm≤max diameter≤4cm
- •Causing appearance , pressure or swallowing symptoms
- •Composition of target nodule: solid or predominantly solid (solid area≥80%)
- •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).
- •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.
Exclusion Criteria
- •The ultrasound report indicated that follicular tumors were not excluded.
- •Known history of thyroid cancer or other neoplasias in the neck region.
- •Head and/or neck disease that prevents hyper-extension of neck.
- •Patients currently in the acute phase of any disease.
- •History of head and neck, pulmonary and systemic infections in the last 2 weeks.
- •The white blood cell test result exceeded the upper limit of the normal range.
- •Tenderness of the thyroid and/or thyroid nodules.
- •History of arrhythmia, coronary heart disease or valvular heart disease, heart failure.
- •The blood pressure is not controlled after the combination of three antihypertensive drugs (SBP ≥ 140 mmHg, DBP ≥ 90 mmHg)
- •COPD history or acute phase of asthma attach
Outcomes
Primary Outcomes
Effectiveness evaluation using treatment effective rate
Time Frame: 12 Months
percentage of patients who achieve treatment success (volume reduction ratio \> 50%) at 12 months after HIFU treatment assessed by ultrasound examination
Secondary Outcomes
- Incidence of Treatment-Emergent Adverse Events(12 Months)
- Symptoms score improvement(12 Months)