Non-malignant Thyroid Nodules
Conditions
Brief summary
Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.
Interventions
DEVICEEchopulse
Sponsors
Theraclion
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patient 18 years or older. * Patient presenting with at least one thyroid nodule with no signs of malignancy: 1. Non suspect clinically and at ultrasonography imaging 2. Benign cytological diagnosis at fine-needle aspiration biopsy (FNAB) from the last 6 months 3. Normal serum calcitonin 4. No history of neck irradiation * Normal thyroid-stimulating hormone (TSH). * Targeted nodule accessible and eligible to HIFU * Absence of abnormal vocal cord mobility at laryngoscopy. * Nodule diameter ≥ 10mm measured by ultrasound. * Nodule volume inferior to 10 cc * Composition of the targeted nodule(s) : no more than 30% cystic
Exclusion criteria
* Head and/or neck disease that prevents hyperextension of neck. * Known history of thyroid cancer or other neoplasias in the neck region. * History of neck irradiation. * Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment * Posterior position of the nodule if the thickness of the nodule is \<15mm * Pregnant or lactating woman * Any contraindication to the assigned analgesia/anaesthesia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US) | Month 6 and Month 12 |
| Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US) | Month 6 and Month 12 |
| Evaluation of thyroid nodule's vascularisation changes following HIFU therapy assessed by ultrasonography (US) | Month 6 and Month 12 |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events as a measure of safety and tolerability | Day 1, Month 1, Month 3, Month 6 and Month 12 |
Countries
Italy
Outcome results
None listed