HIFU vs RAI in the Relapsed Graves' Disease
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|ClinicalTrials.gov Identifier: NCT03013257|
Recruitment Status : Recruiting
First Posted : January 6, 2017
Last Update Posted : October 1, 2019
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: High Intensity Focused Ultrasound
Try to use the machine 'Echopulse' with High Intensity Focused Ultrasound to treat the relapsed Graves' disease
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
- Rate of remission [ Time Frame: 6 months ]Stating of biochemically euthyroid and hypothyroid without ATDs after 6 months of treatment
- 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.
- Change in auto-antibodies [ Time Frame: 6 months ]To examine the changes of anti-thyroid and TSHR after 6 months of treatment
- Change in total thyroid volume [ Time Frame: 6 months ]To measure the change in size of total thyroid volume after 6 months of treatment
- Change in eye disease activity [ Time Frame: 6 months ]To examine the change in eye disease activity (CAS) with 6 months.
- Satisfaction score after treatment [ Time Frame: 6 months ]To measure the satisfaction score (1-10) after treatment
- The pain assessment after treatment [ Time Frame: 6 months ]The pain assessment (scoring 1-10) after treatment
- 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
- 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.
- 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.
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): NCT03013257
|Contact: Hung Hin, Brian Lang, MBBS(Hons)||+852 2255 email@example.com|
|Queen Mary Hospital||Recruiting|
|Hong Kong, Hong Kong, 852|
|Contact: Hung Hin, Brian Lang, MBBS(Hons) +852-22554232 firstname.lastname@example.org|
|Principal Investigator: Hung Hin, Brian Lang, MBBS(Hons)|
|Principal Investigator:||Hung Hin, Brian Lang, MBBS(Hons)||The University of Hong Kong|