search
Back to results

HIFU Treatment of Benign Thyroid Nodules

Primary Purpose

Thyroid Nodule (Benign)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Device: Echopulse (HIFU ablation)
Sponsored by
Theraclion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Nodule (Benign)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Test group HIFU treatment

    Control group

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Symptoms score improvement
    Using Visual Analogic Scale between (0-100 mm) to evaluate the improvement of appearance symptoms, compression symptoms and swallowing symptoms and pain. With 0 being no pain and 100 being the worst pain imaginable
    Incidence of Treatment-Emergent Adverse Events
    Incidence of local and/or general adverse reactions and other related symptoms at 1, 7 days and 1, 3, 6 and 12 months follow-up after treatment

    Full Information

    First Posted
    January 15, 2020
    Last Updated
    June 23, 2023
    Sponsor
    Theraclion
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04233398
    Brief Title
    HIFU Treatment of Benign Thyroid Nodules
    Official Title
    A Multi-center, Randomized, Controlled Trial of High Intensity Focused Ultrasound (HIFU) Treatment of Benign Thyroid Nodules
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Theraclion

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Nodule (Benign)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Test group HIFU treatment
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    Device: Echopulse (HIFU ablation)
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Effectiveness evaluation using treatment effective rate
    Description
    percentage of patients who achieve treatment success (volume reduction ratio > 50%) at 12 months after HIFU treatment assessed by ultrasound examination
    Time Frame
    12 Months
    Secondary Outcome Measure Information:
    Title
    Symptoms score improvement
    Description
    Using Visual Analogic Scale between (0-100 mm) to evaluate the improvement of appearance symptoms, compression symptoms and swallowing symptoms and pain. With 0 being no pain and 100 being the worst pain imaginable
    Time Frame
    12 Months
    Title
    Incidence of Treatment-Emergent Adverse Events
    Description
    Incidence of local and/or general adverse reactions and other related symptoms at 1, 7 days and 1, 3, 6 and 12 months follow-up after treatment
    Time Frame
    12 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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. 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. If there are nodules on the opposite side of HIFU treatment side, one of the following conditions shall be met: Maximum diameter of these nodules is smaller than 1 cm and ultrasound imaging ≤ Grade 3 assessed by 2017 ACR TI-RADS. 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. Absence of abnormal vocal cord mobility at laryngoscopy. Patients reject or cannot tolerate invasive surgical treatment. Patient has signed a written informed consent. 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 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 Woman who Plan to be pregnant during the study period. Any contraindication to the assigned analgesia/ anaesthesia. Patients who participated in other clinical trials in the past 3 months. Alzhemier's patients or patient with cognitive impairment. Other patients judged by the investigators to be unsuitable for the clinical trial.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yao Zhong, Master
    Phone
    +860755-21659096
    Email
    joanna.zhong@theraclion.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jian Kuang, MD
    Organizational Affiliation
    Guangdong Province People's Hopital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    HIFU Treatment of Benign Thyroid Nodules

    We'll reach out to this number within 24 hrs