HIFU Treatment of Benign Thyroid Nodules

NCT04233398 | Not Yet Recruiting DMC

• 1 other identifier: HIFU20190725
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thyroid Nodule (Benign)

Outcome Measures

Primary Outcomes (1)

• Effectiveness evaluation using treatment effective rate

  percentage of patients who achieve treatment success (volume reduction ratio \> 50%) at 12 months after HIFU treatment assessed by ultrasound examination

  12 Months

Secondary Outcomes (2)

• Symptoms score improvement

  12 Months

• Incidence of Treatment-Emergent Adverse Events

  12 Months

Study Arms (2)

Test group HIFU treatment

EXPERIMENTAL

Patients in the test group (120) will be treated with high intensity focused ultrasound (HIFU). 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 (VAS score).

Device: Device: Echopulse (HIFU ablation)

Control group

NO INTERVENTION

Patients in the control group (120) will be actively observed and followed up. 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 (VAS score).

Interventions

Device: Echopulse (HIFU ablation) DEVICE

High-intensity focused ultrasound (HIFU) is a non-invasive, non-invasive treatment method. The principle is to focus high-intensity ultrasound on the target area. Energy is absorbed by the target tissue and converted into thermal energy. The local temperature quickly reaches a maximum of 85 ° C. It induces coagulative necrosis of focus tissue cells, but does not damage the tissues surrounding the treatment targ

Test group HIFU treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• No macro-calcifications in target nodule, macro-calcifications induce a significant shadow in the ultrsound imaging.
• the skin is free from any significant thick scars.
• If there are more than one nodule on the treatment side, all of the following conditions shall be met:
• No more than 2 nodules except the target nodule.
• Maximum diameter of the nodules is smaller than 1 cm and ultrasound imaging ≤ Grade 3 assessed by 2017 ACR TI-RADS.

You may not qualify if:

• 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
• Patients with liver dysfunction ( ALT or AST level 2.5 times higher than the upper limit of the normal reference range)
• Patients with renal insufficiency( eGFR\< 45ml/min/1.73m2).
• Fasting blood glucose \>8mmol/L after hypoglycemic drug treatment
• Patients currently sufferrign from hematological diseases or bleeding tendency, or patients currently requiring continuous administration of antiplatelet and anticoagulant drugs
• Pregnant or lactating woman

Sponsors & Collaborators

• Theraclion: lead

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

Study Officials

• Jian Kuang, MD

  Guangdong Province People's Hopital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao Zhong, Master

CONTACT

+860755-21659096; joanna.zhong@theraclion.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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. during the follow-up period, the follow-up visits time and follow-up examination items (clinical examination, ultrasonic examination and laboratory examination etc.) were the same in the both groups

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: August 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share