Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate thyroid nodule's volume, structure and vascularisation changes following HIFU therapy assessed by ultrasonography

Detailed Description
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HIFU treatment will be performed under conscious sedation under the supervision / responsibilities of an anesthetist. A maximum of 2 HIFU sessions per nodule will be performed per patient. The decision to retreat the patient will be taken at 1 month post-HIFU or later. Follow-up after HIFU treatment D1 after HIFU session: Indirect laryngoscopy to check vocal cord mobility. D7 after HIFU session Clinical examination (skin, local symptoms, oedema, voice….), Ultrasonography and Power Doppler, M1 after HIFU session Clinical examination (skin, local symptoms, oedema, voice….), Ultrasonography and Power Doppler, M3 after HIFU session Clinical examination (skin, local symptoms, oedema, voice….), Ultrasonography and Power Doppler Decision for an additional HIFU course to improve volume reduction. In case of a second HIFU session D7b, M1b and M3b, M6b, M9b, M12b, M18b, M24b and M36b will be performed M6 after last HIFU session Clinical examination (skin, local symptoms, oedema, voice….), Ultrasonography and Power Doppler TSH Free T4 Antithyroid peroxidase antibodies Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery) M9 after HIFU session Clinical examination (skin, local symptoms, oedema, voice….), Ultrasonography and Power Doppler M12 after last HIFU session Clinical examination (skin, local symptoms, oedema, voice….), Ultrasonography and Power Doppler TSH Free T4 Antithyroid peroxidase antibodies Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery) M18, M24, M36 after HIFU session Clinical examination (skin, local symptoms, oedema, voice….), Ultrasonography and Power Doppler

Official Title
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Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.

Conditions
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Non-malignant Thyroid Nodule

Intervention / Treatment
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* Device: HIFU treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient 18 years or older. Patient presenting with at least one thyroid nodule with no signs of malignancy: Non suspect clinically and at ultrasonography imaging Benign cytological diagnosis at FNAB from the last 6 months Normal serum calcitonin No history of neck irradiation Normal TSH. Targeted nodule accessible and eligible to HIFU Absence of abnormal vocal cord mobility at laryngoscopy. Nodule diameter ≥ 10mm measured by ultrasound. 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 IV neurolept analgesia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIFU treatment<br>use of HIFU treatment in patients with non-malignant thyroid nodules | Device: HIFU treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in thyroid nodule's volume |  | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in thyroid nodule's structure and vascularisation |  | Month 6 | 
| Number of participants with adverse events |  | D1, D7, M1, M3 and M6 |