Status:
COMPLETED
HIFU Reapplication in Benign Nodules
Lead Sponsor:
The University of Hong Kong
Conditions:
Thyroid Nodule
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
High Intensity Focused Ultrasound (HIFU) is a new approach in treating benign thyroid nodule without surgery. It is proven effective and safe relative to traditional surgery. From previous HIFU studie...
Detailed Description
Thyroid nodules are common and although most are benign and remain relatively static in size, some can grow and become large and cause local symptoms over time. In such scenario, thyroidectomy is usua...
Eligibility Criteria
Inclusion
- patients age older than 18 years,
- a nodule that has previously been completely treated by single-session HIFU ablation but has not responded adequately (i.e. \<50% volume reduction from baseline after 6 months),
- a benign nodule without signs of malignancy (e.g, nonsuspicious clinical and US appearance, benign results at cytologic examination performed in the last 6 months, normal serum calcitonin level),
- a nodule measuring on US greater than or equal to 10 mm in three orthogonal dimensions,
- less than 30% of the targeted nodule comprising cystic area,
- HIFU accessibility of the targeted nodule (distance between the skin and the anterior surface of the nodule less than 17 mm, with no interference of the collarbone with HIFU unit movements)
- normal thyrotropin concentration and
- absence of vocal cord immobility at laryngoscopy.
Exclusion
- head and/or neck disease preventing hyperextension of the neck,
- history of thyroid cancer or other malignant tumors in the neck region,
- history of neck irradiation,
- intranodular macrocalcifications inducing a shadow substantial enough to preclude treatment with HIFU,
- nodules next to the posterior margin of the thyroid lobe with anteroposterior diameter less than 15 mm,
- pregnancy or lactation,
- any contraindication related to intravenous moderate sedation in the first HIFU treatment.
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2018
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03331172
Start Date
July 1 2017
End Date
August 30 2018
Last Update
October 11 2018
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, Hong Kong