CompletedNot Applicable

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

Hong Kong156 participantsStarted 2020-04-01

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

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

The absolute change in Thyroid nodule volume (TNV) after sequential HIFU treatment and a fixed-dose (370MBq) RAIT after 12 months.

Timeframe: 12 months

Trial details

NCT IDNCT04009863

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-20