Non Toxic Multinodular GoiterNCT04009863
HIFU Ablation vs Fixed-dose RAI-131 Therapy in Moderate-sized Non-toxic MNG
A study testing Echopulse and Radioactive iodine (Radioidine i131) in people with Non Toxic Multinodular Goiter and High Intensity Focused Ultrasound, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Toxic Multinodular Goiter, High Intensity Focused Ultrasound, RAI
- What is being tested?
- Echopulse and Radioactive iodine (Radioidine i131)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2020to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a moderate-sized NMNG. The dimension of the largest nodule cannot exceed 50mm in diameter. Also on USG volumetry, the total combined volume of the three largest nodules (i.e. the largest nodule volume + second largest nodule volume + third largest nodule volume) or in short, TNV cannot exceed 80 mL or cm^3.
- The NMNG has to benign. Each nodule within the goiter will be carefully evaluated on USG by an experienced clinician to look for suspicious features for malignancy. Suspicious-looking nodules will be biopsied by USG-guided FNAC. Only nodules with Bethesda II on FNAC will be considered benign.
- Aged between 18 and 70 years old at the time of informed consent.
- Have genuine cosmetic and/or pressure symptoms.
- Have to have normal serum free T4 (FT4) and thyroid-stimulating hormone (TSH) levels.
Who cannot join
- Have a non-toxic diffuse goiter or a NMNG with the largest nodule < 20mm in diameter.
- Prefer or have a clear indication for thyroidectomy (such as rapidly growing, compressive goiter or suspected or documented thyroid malignancy).
- Have a pre-existing vocal cord palsy.
- Unable to tolerate even slight neck extension during HIFU ablation.
- Pregnant, lactating women or women wishing to become pregnant within 6 months.
- Previous thyroid surgery or neck irradiation.
- Family history of non-medullary thyroid carcinoma.
- Have any medical conditions that would make them too ill to undergo treatment.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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.
Read the detailed description
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).
- Being tested
- Echopulse, Radioactive iodine (Radioidine i131)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchopulseDevice
Also called High Intensity Focused Ultrasound (HIFU)
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
Radioactive iodine (Radioidine i131)Radiation
Radioactive iodine (RAI) is a radioactive form of iodine that for ablation in thyroid disease (i.e. Graves' disease or few thyroid cancer)
| Study group | Role | What they receive |
|---|---|---|
| HIFU on NMNG | Active comparator | The patients with non-toxic multinodular goiter are assigned to have high intensity focused ultrasound treatment. Receives: Device: Echopulse |
| RAI on NMNG | Active comparator | The patients with non-toxic multinodular goiter are assigned to have radioactive iodine (i131) treatment. Receives: Radiation: Radioactive iodine (Radioidine i131) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute change in Thyroid nodule volume (TNV) after sequential HIFU treatment and a fixed-dose (370MBq) RAIT after 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.
Measured: 12 months
Secondary outcomes (9)
Change in total thyroid volume (TTV) (in cm^3)
To compare the absolute change in TTV between HIFU and RAIT groups
Measured: 12 months
Change in the largest/dominant nodule dimensions
To compare the change in the largest/dominant nodule dimensions (in cm) between HIFU and RAIT groups
Measured: 12 months
Incidence of treatment-related morbidities after HIFU/RAIT
To compare incidence of treatment-related morbidities and hypothyroidism between HIFU and RAIT groups
Measured: 12 months
Change in World Health Organization goiter grade
To compare WHO goiter grade over time between HIFU and RAIT groups
Measured: 12 months
Change in symptom improvement score
To compare symptom improvement score (0-10) over time between HIFU and RAIT groups
Measured: 12 months
Change in pressure symptom score
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.
Measured: 12 months
Change in quality of life
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.
Measured: 12 months
Change in patient satisfaction
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
Measured: 12 months
Compare the costs (in dollars)
To compare the direct and indirect costs between HIFU and RAIT (in dollars)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Apr 2020
- Primary completion20 Feb 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Non Toxic Multinodular GoiterStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group 1 is for HIFU treatment, group 2 is for RAI treatment
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lang Hung Hin, Brian, The University of Hong Kong
- Investigators
- Hung Hin Brian Lang, MBBS(Hons), Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009863
- Sponsor's protocol ID
- UW 19-016
- Status last verified
- May 2022
- First submitted
- 26 Jun 2019
- Last updated
- 20 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gharib H, Papini E, Garber JR, Duick DS, Harrell RM, Hegedus L, Paschke R, Valcavi R, Vitti P; AACE/ACE/AME Task Force on Thyroid Nodules. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS, AMERICAN COLLEGE OF ENDOCRINOLOGY, AND ASSOCIAZIONE MEDICI ENDOCRINOLOGI MEDICAL GUIDELINES FOR CLINICAL PRACTICE FOR THE DIAGNOSIS AND MANAGEMENT OF THYROID NODULES--2016 UPDATE. Endocr Pract. 2016 May;22(5):622-39. doi: 10.4158/EP161208.GL.
PubMed 27167915Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
PubMed 26462967Durante C, Costante G, Lucisano G, Bruno R, Meringolo D, Paciaroni A, Puxeddu E, Torlontano M, Tumino S, Attard M, Lamartina L, Nicolucci A, Filetti S. The natural history of benign thyroid nodules. JAMA. 2015 Mar 3;313(9):926-35. doi: 10.1001/jama.2015.0956.
PubMed 25734734Gharib H, Hegedus L, Pacella CM, Baek JH, Papini E. Clinical review: Nonsurgical, image-guided, minimally invasive therapy for thyroid nodules. J Clin Endocrinol Metab. 2013 Oct;98(10):3949-57. doi: 10.1210/jc.2013-1806. Epub 2013 Aug 16.
PubMed 23956350Sung JY, Baek JH, Kim KS, Lee D, Yoo H, Kim JK, Park SH. Single-session treatment of benign cystic thyroid nodules with ethanol versus radiofrequency ablation: a prospective randomized study. Radiology. 2013 Oct;269(1):293-300. doi: 10.1148/radiol.13122134. Epub 2013 Apr 24.
PubMed 23616630Lang BH, Woo YC, Wong CKH. High-Intensity Focused Ultrasound for Treatment of Symptomatic Benign Thyroid Nodules: A Prospective Study. Radiology. 2017 Sep;284(3):897-906. doi: 10.1148/radiol.2017161640. Epub 2017 Apr 18.
PubMed 28419814Bonnema SJ, Hegedus L. Radioiodine therapy in benign thyroid diseases: effects, side effects, and factors affecting therapeutic outcome. Endocr Rev. 2012 Dec;33(6):920-80. doi: 10.1210/er.2012-1030. Epub 2012 Sep 7.
PubMed 22961916Paschke R, Hegedus L, Alexander E, Valcavi R, Papini E, Gharib H. Thyroid nodule guidelines: agreement, disagreement and need for future research. Nat Rev Endocrinol. 2011 Jun;7(6):354-61. doi: 10.1038/nrendo.2011.1. Epub 2011 Mar 1.
PubMed 21364517Dossing H, Bennedbaek FN, Bonnema SJ, Grupe P, Hegedus L. Randomized prospective study comparing a single radioiodine dose and a single laser therapy session in autonomously functioning thyroid nodules. Eur J Endocrinol. 2007 Jul;157(1):95-100. doi: 10.1530/EJE-07-0094.
PubMed 17609407Mader A, Mader OM, Groner D, Korkusuz Y, Ahmad S, Grunwald F, Kranert WT, Happel C. Minimally invasive local ablative therapies in combination with radioiodine therapy in benign thyroid disease: preparation, feasibility and efficiency - preliminary results. Int J Hyperthermia. 2017 Dec;33(8):895-904. doi: 10.1080/02656736.2017.1320813. Epub 2017 May 5.
PubMed 28540810Lang BHH, Woo YC, Chiu KW. Sequential high intensity focused ultrasound (HIFU) ablation in the treatment of benign multinodular goitre: an observational retrospective study. Eur Radiol. 2018 Aug;28(8):3237-3244. doi: 10.1007/s00330-018-5333-2. Epub 2018 Mar 19.
PubMed 29556769Lang BH, Woo YC, Chiu KW. Single-Session High-Intensity Focused Ultrasound Treatment in Large-Sized Benign Thyroid Nodules. Thyroid. 2017 May;27(5):714-721. doi: 10.1089/thy.2016.0664. Epub 2017 Mar 22.
PubMed 28326895Eng OS, Potdevin L, Davidov T, Lu SE, Chen C, Trooskin SZ. Does nodule size predict compressive symptoms in patients with thyroid nodules? Gland Surg. 2014 Nov;3(4):232-6. doi: 10.3978/j.issn.2227-684X.2014.08.03.
PubMed 25493254Zimmermann M, Saad A, Hess S, Torresani T, Chaouki N. Thyroid ultrasound compared with World Health Organization 1960 and 1994 palpation criteria for determination of goiter prevalence in regions of mild and severe iodine deficiency. Eur J Endocrinol. 2000 Dec;143(6):727-31. doi: 10.1530/eje.0.1430727.
PubMed 11124854Lang BHH, Woo YC, Chiu KW. Significance of hyperechoic marks observed during high-intensity focused ultrasound (HIFU) ablation of benign thyroid nodules. Eur Radiol. 2018 Jun;28(6):2675-2681. doi: 10.1007/s00330-017-5207-z. Epub 2018 Jan 8.
PubMed 29313120
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04009863
- Acronym / sponsor ID
- UW 19-016
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- group 1 is for HIFU treatment, group 2 is for RAI treatment
| Arm | Type | Receives |
|---|---|---|
| HIFU on NMNG | Active comparator | Device: EchopulseThe patients with non-toxic multinodular goiter are assigned to have high intensity focused ultrasound treatment. |
| RAI on NMNG | Active comparator | Radiation: Radioactive iodine (Radioidine i131)The patients with non-toxic multinodular goiter are assigned to have radioactive iodine (i131) treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a moderate-sized NMNG. The dimension of the largest nodule cannot exceed 50mm in diameter. Also on USG volumetry, the total combined volume of the three largest nodules (i.e. the largest nodule volume + second largest nodule volume + third largest nodule volume) or in short, TNV cannot exceed 80 mL or cm^3.
- The NMNG has to benign. Each nodule within the goiter will be carefully evaluated on USG by an experienced clinician to look for suspicious features for malignancy. Suspicious-looking nodules will be biopsied by USG-guided FNAC. Only nodules with Bethesda II on FNAC will be considered benign.
- Aged between 18 and 70 years old at the time of informed consent.
- Have genuine cosmetic and/or pressure symptoms.
- Have to have normal serum free T4 (FT4) and thyroid-stimulating hormone (TSH) levels.
Key exclusion criteria (8 listed)
- Have a non-toxic diffuse goiter or a NMNG with the largest nodule < 20mm in diameter.
- Prefer or have a clear indication for thyroidectomy (such as rapidly growing, compressive goiter or suspected or documented thyroid malignancy).
- Have a pre-existing vocal cord palsy.
- Unable to tolerate even slight neck extension during HIFU ablation.
- Pregnant, lactating women or women wishing to become pregnant within 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchopulseAlso: High Intensity Focused Ultrasound (HIFU)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 | Device | HIFU on NMNG |
| 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) | Radiation | RAI on NMNG |
Primary outcome
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.
9 secondary outcomes
Change in total thyroid volume (TTV) (in cm^3)
Time frame: 12 months
Change in the largest/dominant nodule dimensions
Time frame: 12 months
Incidence of treatment-related morbidities after HIFU/RAIT
Time frame: 12 months
Change in World Health Organization goiter grade
Time frame: 12 months
Change in symptom improvement score
Time frame: 12 months
Change in pressure symptom score
Time frame: 12 months
Change in quality of life
Time frame: 12 months
Change in patient satisfaction
Time frame: 12 months
Compare the costs (in dollars)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Background: PubMed 27167915Gharib H, Papini E, Garber JR, Duick DS, Harrell RM, Hegedus L, Paschke R, Valcavi R, Vitti P; AACE/ACE/AME Task Force on Thyroid Nodules. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS, AMERICAN COLLEGE OF ENDOCRINOLOGY, AND ASSOCIAZIONE MEDICI ENDOCRINOLOGI MEDICAL GUIDELINES FOR CLINICAL PRACTICE FOR THE DIAGNOSIS AND MANAGEMENT OF THYROID NODULES--2016 UPDATE. Endocr Pract. 2016 May;22(5):622-39. doi: 10.4158/EP161208.GL.
- Background: PubMed 26462967Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
- Background: PubMed 25734734Durante C, Costante G, Lucisano G, Bruno R, Meringolo D, Paciaroni A, Puxeddu E, Torlontano M, Tumino S, Attard M, Lamartina L, Nicolucci A, Filetti S. The natural history of benign thyroid nodules. JAMA. 2015 Mar 3;313(9):926-35. doi: 10.1001/jama.2015.0956.
- Background: PubMed 23956350Gharib H, Hegedus L, Pacella CM, Baek JH, Papini E. Clinical review: Nonsurgical, image-guided, minimally invasive therapy for thyroid nodules. J Clin Endocrinol Metab. 2013 Oct;98(10):3949-57. doi: 10.1210/jc.2013-1806. Epub 2013 Aug 16.
- Background: PubMed 23616630Sung JY, Baek JH, Kim KS, Lee D, Yoo H, Kim JK, Park SH. Single-session treatment of benign cystic thyroid nodules with ethanol versus radiofrequency ablation: a prospective randomized study. Radiology. 2013 Oct;269(1):293-300. doi: 10.1148/radiol.13122134. Epub 2013 Apr 24.
- Background: PubMed 28419814Lang BH, Woo YC, Wong CKH. High-Intensity Focused Ultrasound for Treatment of Symptomatic Benign Thyroid Nodules: A Prospective Study. Radiology. 2017 Sep;284(3):897-906. doi: 10.1148/radiol.2017161640. Epub 2017 Apr 18.
- Background: PubMed 22961916Bonnema SJ, Hegedus L. Radioiodine therapy in benign thyroid diseases: effects, side effects, and factors affecting therapeutic outcome. Endocr Rev. 2012 Dec;33(6):920-80. doi: 10.1210/er.2012-1030. Epub 2012 Sep 7.
- Background: PubMed 21364517Paschke R, Hegedus L, Alexander E, Valcavi R, Papini E, Gharib H. Thyroid nodule guidelines: agreement, disagreement and need for future research. Nat Rev Endocrinol. 2011 Jun;7(6):354-61. doi: 10.1038/nrendo.2011.1. Epub 2011 Mar 1.
- Background: PubMed 17609407Dossing H, Bennedbaek FN, Bonnema SJ, Grupe P, Hegedus L. Randomized prospective study comparing a single radioiodine dose and a single laser therapy session in autonomously functioning thyroid nodules. Eur J Endocrinol. 2007 Jul;157(1):95-100. doi: 10.1530/EJE-07-0094.
- Background: PubMed 28540810Mader A, Mader OM, Groner D, Korkusuz Y, Ahmad S, Grunwald F, Kranert WT, Happel C. Minimally invasive local ablative therapies in combination with radioiodine therapy in benign thyroid disease: preparation, feasibility and efficiency - preliminary results. Int J Hyperthermia. 2017 Dec;33(8):895-904. doi: 10.1080/02656736.2017.1320813. Epub 2017 May 5.
- Background: PubMed 29556769Lang BHH, Woo YC, Chiu KW. Sequential high intensity focused ultrasound (HIFU) ablation in the treatment of benign multinodular goitre: an observational retrospective study. Eur Radiol. 2018 Aug;28(8):3237-3244. doi: 10.1007/s00330-018-5333-2. Epub 2018 Mar 19.
- Background: PubMed 28326895Lang BH, Woo YC, Chiu KW. Single-Session High-Intensity Focused Ultrasound Treatment in Large-Sized Benign Thyroid Nodules. Thyroid. 2017 May;27(5):714-721. doi: 10.1089/thy.2016.0664. Epub 2017 Mar 22.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung Hin Brian Lang, MBBS(Hons) principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echopulse and Radioactive iodine (Radioidine i131) in people with Non Toxic Multinodular Goiter and High Intensity Focused Ultrasound, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04009863, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.