HIFU Ablation vs Fixed-dose RAI-131 Therapy in Moderate-sized Non-toxic MNG

NCT04009863 | Completed

• 1 other identifier: UW 19-016
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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). 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:

1. 1.Mild bruising and redness at the site of treatment
2. 2.Edema of the skin tissue
3. 3.Pain/discomfort during the procedure
4. 4.Skin burns but rare (\<1%)
5. 5.Vocal cord paresis on the side of the treated lobe but rare (\<1%)
6. 6.Unintentional damage to the surrounding tissue (outside the planned treatment area).

Conditions

Non Toxic Multinodular Goiter; High Intensity Focused Ultrasound; RAI

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (9)

• Change in total thyroid volume (TTV) (in cm^3)

  12 months

• Change in the largest/dominant nodule dimensions

  12 months

• Incidence of treatment-related morbidities after HIFU/RAIT

  12 months

• Change in World Health Organization goiter grade

  12 months

• Change in symptom improvement score

  12 months

Study Arms (2)

HIFU on NMNG

ACTIVE COMPARATOR

The patients with non-toxic multinodular goiter are assigned to have high intensity focused ultrasound treatment.

Device: Echopulse

RAI on NMNG

ACTIVE COMPARATOR

The patients with non-toxic multinodular goiter are assigned to have radioactive iodine (i131) treatment.

Radiation: Radioactive iodine (Radioidine i131)

Interventions

Echopulse DEVICE

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

Also known as: High Intensity Focused Ultrasound (HIFU)

HIFU on NMNG

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)

RAI on NMNG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (18)

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  PMID: 27167915 BACKGROUND

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• Gharib 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.

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  PMID: 28419814 BACKGROUND

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• Paschke 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.

  PMID: 21364517 BACKGROUND

• Dossing 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.

  PMID: 17609407 BACKGROUND

• Mader 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.

  PMID: 28540810 BACKGROUND

• Lang 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.

  PMID: 29556769 BACKGROUND

• Lang 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.

  PMID: 28326895 BACKGROUND

• Eng 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.

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• Zimmermann 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.

  PMID: 11124854 BACKGROUND

• Lang 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.

  PMID: 29313120 BACKGROUND

• Wong KP, Lang BH, Ng SH, Cheung CY, Chan CT, Lo CY. A prospective, assessor-blind evaluation of surgeon-performed transcutaneous laryngeal ultrasonography in vocal cord examination before and after thyroidectomy. Surgery. 2013 Dec;154(6):1158-64; discussion 1164-5. doi: 10.1016/j.surg.2013.04.063. Epub 2013 Aug 19.

  PMID: 23969288 BACKGROUND

• Royal College of Physicians. Radioiodine in the management of benign thyroid disease: clinical guidelines. Report of a Working Party. London: RCP, 2007. Available from: http://www.thyroiduk.org.uk/tuk/guidelines/Radioiodine%20guidelines%202007.pdf

  BACKGROUND

• Hospital Authority. 2013. Revisions to List of charges: G.N. 1488 to Gazette No. 12/2013. In Hong Kong Government Printers. Available: http://www.gld.gov.hk/egazette/english/gazette/toc.php [Accessed at 1st February 2018]

  BACKGROUND

Study Officials

• Hung Hin Brian Lang, MBBS(Hons)

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: group 1 is for HIFU treatment, group 2 is for RAI treatment

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 5, 2019
• Study Start: April 1, 2020
• Primary Completion: February 20, 2022
• Study Completion: April 30, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

HK (1)