Status:
SUSPENDED
A Trial Comparing USG-HIFU vs AS in Management of Low-risk PTMC
Lead Sponsor:
The University of Hong Kong
Conditions:
Papillary Thyroid Microcarcinoma
Eligibility:
All Genders
19-74 years
Phase:
NA
Brief Summary
Papillary thyroid microcarcinoma (PTMC) is a common tumor in Hong Kong. Early immediate surgery has traditionally been recommended. However, given its excellent prognosis, some have recommended Active...
Detailed Description
Differentiated thyroid cancer has been rising in incidence and is expected to be a leading cancer by the year 2030 . However, the rise has been mostly attributed to an increased detection of incidenta...
Eligibility Criteria
Inclusion
- Have a thyroid nodule ≤10mm in the largest dimension that is confirmed on FNAC to be PTC (Bethesda class VI cytology) or suspicious of PTC (Bethesda V cytology). For the latter, the nodule needs to have an additional suspicious sonographic feature (i.e. marked hypoechogenicity, irregular margins, height-to-wide ratio \>1 and intravascular microcalcifications);
- Have not expressed a strong desire for immediate surgery after PTMC has been confirmed.
Exclusion
- Age ≤ 18 or ≥ 75 years old;
- Have another thyroid nodule that is either indeterminate or malignant on FNAC;
- Have concomitant hypo- or hyperthyroidism (i.e. thyroid stimulating hormone (TSH) and/or free thyroxine levels outside the normal ranges)
- Have sonographic evidence of chronic lymphocytic thyroiditis (because this generally makes it difficult to assess and reassess tumor size accurately on USG alone)
- Have a tumor considered not suitable for AS. This includes a PTMC with extrathyroidal extension, concomitant nodal or distant metastasis or a PTMC located within 3mm from trachea-esophageal groove or recurrent laryngeal nerve.
- Have a condition considered not suitable for HIFU treatment (pregnancy, history of neck irradiation, known contralateral vocal cord palsy, a tumor with coarse, macroscopic intranodular calcifications or located outside the treatable depth of 5-30 mm from the skin, family history of non-medullary thyroid carcinoma and medical conditions precluding intravenous sedation).
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03327636
Start Date
October 1 2022
End Date
December 31 2024
Last Update
May 18 2022
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, Hong Kong