Status:
COMPLETED
HIFU Ablation vs Fixed-dose RAI-131 Therapy in Moderate-sized Non-toxic MNG
Lead Sponsor:
The University of Hong Kong
Conditions:
Non Toxic Multinodular Goiter
High Intensity Focused Ultrasound
Eligibility:
All Genders
18-70 years
Phase:
NA
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 treatm...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04009863
Start Date
April 1 2020
End Date
April 30 2022
Last Update
May 20 2022
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, Hong Kong