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A Prospective Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Benign Thyroid Nodules

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ClinicalTrials.gov Identifier: NCT02658552
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Lang Hung Hin, Brian, The University of Hong Kong

Study Description
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Brief Summary:
To evaluate the short-term efficacy of high intensity focused ultrasound (HIFU) in the treatment of benign thyroid nodules

Condition or disease Intervention/treatment Phase
Benign Thyroid Nodules Device: Echopulse Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Benign Thyroid Nodules
Study Start Date : October 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : July 2016

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Drug Information available for: Thyroid

Arms and Interventions
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Arm Intervention/treatment
Experimental: HIFU treatment
To collect the data after HIFU treatment
 Device: Echopulse
Echopulse is a real-time US-guided High-intensity focused ultrasound (HIFU) system, the HIFU session is a noninvasive procedure that involves application of a focused high-energy ultrasound beam for thermal tissue ablation inside the targeted zone, with minimal effect on the surrounding tissue


Outcome Measures
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Primary Outcome Measures :
  1. The changing volume of benign thyroid nodule after HIFU treatment [ Time Frame: 6 months ]
    Change in volume (ml) of the targeted benign thyroid nodule 6 months after one successful course of HIFU

  2. The changing greatest dimension of benign thyroid nodule after HIFU treatment [ Time Frame: 6 months ]
    Change in greatest dimension (in mm) of the targeted benign thyroid nodule 6 months after one successful course of HIFU


Secondary Outcome Measures :
  1. The pain assessment (scoring 1-10) after treatment [ Time Frame: 6 months ]
    Patient pain score immediately after completion of HIFU treatment session.

  2. Incidence of local/ or general adverse events [ Time Frame: 6 months ]
    The incidence rate of local or general adverse events after completion of HIFU treatment session.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patient 18 years or older.

  • Patient presenting with at least one thyroid nodule with no signs of malignancy:

    1. Non suspicious clinically and at ultrasonography imaging
    2. Benign cytological diagnosis at fine needle aspiration biopsy in the last 6 months
    3. Normal serum calcitonin
    4. No history of neck irradiation
  • Serum TSH and free T4 levels within the normal range
  • Targeted nodule deemed to be accessible and eligible to HIFU
  • Absence of vocal cord paresis at laryngoscopy
  • Nodule greatest diameter between ≥10 - 20mm as measured by ultrasound
  • Composition of the targeted nodule(s) : predominantly solid
  • Patient is mentally competent and has given informed consent.

Exclusion Criteria:

  • Head and/or neck disease that prevents extension of neck
  • Known history of thyroid cancer or other malignant tumors in the neck region
  • History of neck irradiation
  • Intranodular macrocalcification inducing a shadow in the thyroid significant enough to preclude HIFU treatment
  • A nodule next to the posterior margin of the lobe with distance <15mm
  • Pregnant or lactating woman
  • Any contraindication to the assigned analgesia/anaesthesia.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658552


Locations
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Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Hung Hin, Brian Lang, MBBS(Hons) The University of Hong Kong
More Information
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Publications:

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Responsible Party: Dr. Lang Hung Hin, Brian, Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02658552    
Other Study ID Numbers: UW15-486
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Keywords provided by Dr. Lang Hung Hin, Brian, The University of Hong Kong:
HIFU
Benign thyroid nodule
Low risk
New treatment
Additional relevant MeSH terms:
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Thyroid Nodule
Thyroid Diseases
Endocrine System Diseases
Thyroid Neoplasms
 Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms