HIFU Ablation vs Fixed-dose RAI-131 Therapy in Moderate-sized Non-toxic MNG
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|ClinicalTrials.gov Identifier: NCT04009863|
Recruitment Status : Not yet recruiting
First Posted : July 4, 2019
Last Update Posted : July 8, 2019
After obtaining informed consent, eligible subjects will be assigned randomly into either High intensity focused ultrasound group (HIFU) or Radioactive iodine (131I) therapy group (RAIT). After treatment, they will be followed up for 4 visits (1-month, 3-month, 6- month, 12-month of post treatment). At each visit, they will have physical examination, regular blood test and questionnaire to evaluate their quality of life. The collected data will be used to compare the effectiveness between HIFU and RAIT for non-toxic multi-nodular goiter (NMNG). The primary purepose is to find out the best non-invasive way in treating NMNG.
For HIFU, you may experience:
- Mild bruising and redness at the site of treatment
- Edema of the skin tissue
- Pain/discomfort during the procedure
- Skin burns but rare (<1%)
- Vocal cord paresis on the side of the treated lobe but rare (<1%)
- Unintentional damage to the surrounding tissue (outside the planned treatment area).
For RAIT, you may experience neck tenderness or sore throat in the following few days as developing moderate inflammation in the thyroid and producing discomfort in the neck or throat area. Your symptoms may turn worse for first few week, but will improve over weeks.
|Condition or disease||Intervention/treatment||Phase|
|Non Toxic Multinodular Goiter High Intensity Focused Ultrasound RAI||Device: Echopulse Radiation: Radioactive iodine (Radioidine i131)||Not Applicable|
Non-toxic multinodular goiter (NMNG) is a condition referred to as a nodular enlargement of the thyroid gland due to the presence of two or more nodules without clinical hyper- or hypothyroidism. It is undoubtedly one of the most common thyroid disorders worldwide and it is estimated that more than 5% of the female population have a clinically-palpable NMNG (1,2).
Although the majority of NMNGs do not cause symptoms and therefore, do not require any intervention other than simple surveillance, some can cause local pressure symptoms and cosmetic concerns over time (1-3).
For NMNGs that cause symptoms, the most widely-accepted treatment has been surgical resection either in the form of a hemithyroidectomy or total thyroidectomy. Despite being safe when done in experienced hands, surgery is associated with complications such as recurrent laryngeal nerve injury and hypoparathyroidism, both of which can be permanent. In addition, a general anesthesia is almost inevitably required when surgery is performed. As a result, non-surgical thermal ablation techniques have been increasingly recognized as an alternative treatment in symptomatic NMNG (4). These ablation techniques utilize thermal energy to cause shrinkage of adenomatous nodules and thereby, relieve symptoms. Types of ablation include radiofrequency, laser and microwave ablations and more recently, high intensity focused ultrasound (HIFU). Regardless of which ablation technique, they have all been shown to not only induce significant nodule shrinkage but also alleviate symptoms (4-6). Radioactive iodine (131I) therapy (RAIT) is another promising non-surgical alterative which is recommended in patients who refuse or have contraindications for surgery. Despite being a less recognized treatment in both Asia and North America, this treatment has increasingly been adopted. In some European countries such as Denmark and Netherlands, it has replaced surgery as the treatment of choice in moderately-sized NMNG as recommended in recently-published clinical practice guidelines (1,7,8). However, RAIT has limitations. For example, it is less applicable in very large-sized NMNG (>100 mL) because large goiters tend to have a lower radioiodine uptake leading to suboptimal shrinkage. Also considerable inconsistency in goiter shrinkage has been reported (7). With our population getting older and the general public placing a greater emphasis on preserving organ function and lessinvasive treatments, non-surgical treatment alternatives will have an increasing role in the future treatment of NMNG. To our knowledge, it remains unknown whether one particular treatment modality is superior over the other modality because there has not been any direct comparison between the two modalities. Only one previous study compared treatment efficacy between laser ablation and RAIT. However, it mainly focused on the treatment of toxic thyroid nodules (9). To enhance treatment efficacy, a recent study reported promising results of combining the effect of thermal ablation and RAIT (10).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||group 1 is for HIFU treatment, group 2 is for RAI treatment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Randomized, Open-label, Parallel-group Study to Determine the Efficacy of Sequential High-intensity Focused Ultrasound (HIFU) Ablation Versus Fixed-dose Radioiodine-131 Therapy in Moderate-sized Non-toxic Multinodular Goiter|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||September 30, 2022|
Active Comparator: HIFU on NMNG
The patients with non-toxic multinodular goiter are assigned to have high intensity focused ultrasound treatment.
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
Other Name: High Intensity Focused Ultrasound (HIFU)
Active Comparator: RAI on NMNG
The patients with non-toxic multinodular goiter are assigned to have radioactive iodine (i131) treatment.
Radiation: Radioactive iodine (Radioidine i131)
Radioactive iodine (RAI) is a radioactive form of iodine that for ablation in thyroid disease (i.e. Graves' disease or few thyroid cancer)
- The absolute change in Thyroid nodule volume (TNV) after sequential HIFU treatment and a fixed-dose (370MBq) RAIT after 12 months. [ Time Frame: 12 months ]To compare the absolute change in Thyroid nodule volume (in cm^3) after sequential HIFU treatment and a fixed-dose (370MBq) RAIT after 12 months.
- Change in total thyroid volume (TTV) (in cm^3) [ Time Frame: 12 months ]To compare the absolute change in TTV between HIFU and RAIT groups
- Change in the largest/dominant nodule dimensions [ Time Frame: 12 months ]To compare the change in the largest/dominant nodule dimensions (in cm) between HIFU and RAIT groups
- Incidence of treatment-related morbidities after HIFU/RAIT [ Time Frame: 12 months ]To compare incidence of treatment-related morbidities and hypothyroidism between HIFU and RAIT groups
- Change in World Health Organization goiter grade [ Time Frame: 12 months ]To compare WHO goiter grade over time between HIFU and RAIT groups
- Change in symptom improvement score [ Time Frame: 12 months ]To compare symptom improvement score (0-10) over time between HIFU and RAIT groups
- Change in pressure symptom score [ Time Frame: 12 months ]To assess the changes in pressure symptom score (by Visual Analogue Scale, VAS, scoring from 0-10, 0 is for no pressure and 10 is for the maximum pressure feeling as subjects' view) over time between the HIFU and RAIT groups.
- Change in quality of life [ Time Frame: 12 months ]To assess the changes in quality of life (QOL) using by "12-Item Short Form Survey (SF-12) (VERSION 2.0)" between the two treatment groups. SF-12 is scoring 70 in total, the higher score represent higher quality of life.
- Change in patient satisfaction [ Time Frame: 12 months ]To assess the changes in patient satisfaction (by Visual Analogue Scale, VAS, scoring from 0-10, 10 is for the maximum score representing well satisfaction) between the two treatment groups
- Compare the costs (in dollars) [ Time Frame: 12 months ]To compare the direct and indirect costs between HIFU and RAIT (in dollars)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04009863
|Contact: Hung Hin Brian Lang, MBBS(Hons)||+firstname.lastname@example.org|
|Queen Mary Hospital|
|Hong Kong, Hong Kong|
|Principal Investigator:||Hung Hin Brian Lang, MBBS(Hons)||The University of Hong Kong|