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HIFU vs RAI in the Relapsed Graves' Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03013257
Recruitment Status : Recruiting
First Posted : January 6, 2017
Last Update Posted : October 1, 2019
Information provided by (Responsible Party):
Dr. Lang Hung Hin, Brian, The University of Hong Kong

Brief Summary:

Graves' disease (GD) is an autoimmune thyroid disorder caused by stimulating auto-antibodies to the thyrotrophin (TSH) receptor on thyroid follicular cells. It is the most common cause of hyperthyroidism and approximately 3% of women and 0.5% of men develop GD in their lifetime.

RAI has been shown to be a cost-effective and safe therapy in patients with GD but with some disadvantages. In addition, despite its proven efficacy and safety, many patients do not wish to undergo RAI because of radiation fear and prefer to either continue ATDs or have surgery.

High-intensity focused ultrasound (HIFU) is a non-invasive procedure that involves the application of a high-energy focused beam for thermal tissue ablation within a targeted zone. Similar to the principle of RAI (i.e. using ionizing radiation to ablate thyroid parenchyma and cause GD remission), we postulated that the heat energy generated from HIFU could also be used to ablate the thyroid parenchyma and cause GD remission. The idea of using heat energy to ablate thyroid parenchyma minimally invasively was recently reported using radiofrequency ablation but to our knowledge, we are one of the first (if not the first) group to propose using HIFU energy to ablate thyroid parenchyma as a definitive treatment for relapsed GD.

Having obtained ethical approval, a pilot study was conducted to examine the efficacy and safety of HIFU as a treatment for relapsed GD. In the pilot study, all patients underwent a safe and successful HIFU ablation for relapsed GD. Based on the results of the pilot study, we hypothesize that a single HIFU treatment to the thyroid gland may be as effective as our standard outpatient fixed-dose of RAI (370MBq) in causing remission of GD at 6-month. If our hypothesis turns out to be true, HIFU could become a treatment option for patients who are indicated for RAI but do not wish to have it because of one reason or another. HIFU appears to induce a faster disease remission and lessen the need of deferring pregnancy and radiation precautions because of the absence of radioactivity.

Condition or disease Intervention/treatment Phase
Graves Disease Device: Echopulse Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Parallel-group Study to Explore the Efficacy of High-intensity Focused Ultrasound (HIFU) Versus Fixed-dose Radioiodine-131 in the Treatment of Relapsed Graves' Disease
Actual Study Start Date : April 25, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: High Intensity Focused Ultrasound
Try to use the machine 'Echopulse' with High Intensity Focused Ultrasound to treat the relapsed Graves' disease
Device: Echopulse
Replacing HIFU for the Graves' disease patients who traditionally have RAI to remission
Other Name: High Intensity Focused Ultrasound (HIFU)

No Intervention: Fixed-dose radioiodine-131
Using the traditional treatment, fixed-dose radioiodine-131, to treat the relapsed Graves' disease

Primary Outcome Measures :
  1. Rate of remission [ Time Frame: 6 months ]
    Stating of biochemically euthyroid and hypothyroid without ATDs after 6 months of treatment

Secondary Outcome Measures :
  1. Incidence of treatment-related morbidities from day-0 to post 2-week [ Time Frame: 2 weeks ]
    To examine any treatment-related morbidities after the treatment within 2 weeks.

  2. Change in auto-antibodies [ Time Frame: 6 months ]
    To examine the changes of anti-thyroid and TSHR after 6 months of treatment

  3. Change in total thyroid volume [ Time Frame: 6 months ]
    To measure the change in size of total thyroid volume after 6 months of treatment

  4. Change in eye disease activity [ Time Frame: 6 months ]
    To examine the change in eye disease activity (CAS) with 6 months.

  5. Satisfaction score after treatment [ Time Frame: 6 months ]
    To measure the satisfaction score (1-10) after treatment

  6. The pain assessment after treatment [ Time Frame: 6 months ]
    The pain assessment (scoring 1-10) after treatment

  7. Change in Quality of life [ Time Frame: 6 months ]
    To examine the change in qualitfy of life with SF-12 scores from baseline to 2-month and 6-month

  8. The medical costs [ Time Frame: 6 months ]
    To evaluate the cost of different treatments including direct medical costs (including treatment, investigations, unplanned readmission and visits) and indirect costs (such as number of days before returning to normal activities and work). Medical costs will be based on the latest Government Gazette.

  9. The effectiveness of HIFU treatment [ Time Frame: 6 months ]
    The effectiveness of HIFU will be quantified by quality-adjusted left years (QALYs), which will be calculated as the product of the average duration of that stage and SF-6D preference value (i.e. from SF-12) for the particular health state.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. A diagnosis of GD based on standard clinical criteria (elevated thyroid hormone levels, suppressed TSH, positive TSHR auto-antibody, diffuse goiter ± high RAI uptake).
  2. Aged between 18 and 70 years old at the time of informed consent
  3. Have had at least one GD relapse. A relapse is defined as recurrent or persistent hyperthyroidism despite completing a continued course of ATDs for 18 months or more.
  4. Indicated for RAI treatment
  5. Valid consent is obtained

Exclusion Criteria:

  1. Prefer or have clear indications for surgery (such as those with large compressive goiter, suspected or documented thyroid malignancy, wishing to become pregnant within 6 months or with moderate to severe GO).
  2. Have pre-existing vocal cord palsy
  3. Are unable to move or extend their neck
  4. Have either right, left or central (isthmic) lobe measuring >30ml in volume on pre-treatment USG volumetry (see later)
  5. Have concomitant thyroid nodules which are either indeterminate, suspicious of malignancy or proven malignant on fine needle aspiration cytology (FNAC).
  6. Have active or severe Graves ophthalmopathy (GO)
  7. Are pregnant, lactating or planning for pregnancy within 6 months
  8. Have any medical conditions that would make them too ill to undergo intravenous sedation or treatment
  9. Any condition that is unstable or can jeopardize the safety of the patients and their compliance to the study

Information from the National Library of Medicine

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 identifier (NCT number): NCT03013257

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Contact: Hung Hin, Brian Lang, MBBS(Hons) +852 2255 4232

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Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong, 852
Contact: Hung Hin, Brian Lang, MBBS(Hons)    +852-22554232   
Principal Investigator: Hung Hin, Brian Lang, MBBS(Hons)         
Sponsors and Collaborators
The University of Hong Kong
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Principal Investigator: Hung Hin, Brian Lang, MBBS(Hons) The University of Hong Kong

Additional Information:

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Responsible Party: Dr. Lang Hung Hin, Brian, Clinical Associate Professor, The University of Hong Kong Identifier: NCT03013257     History of Changes
Other Study ID Numbers: UW 16-565
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Lang Hung Hin, Brian, The University of Hong Kong:
Relapsed Graves' disease
High Intensity Focused Ultrasound
Additional relevant MeSH terms:
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Graves Disease
Orbital Diseases
Eye Diseases
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases