Non-malignant Thyroid Nodule
Conditions
Brief summary
The purpose of this study is to evaluate thyroid nodule's volume, structure and vascularisation changes following HIFU therapy assessed by ultrasonography
Detailed description
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
Interventions
DEVICEHIFU treatment
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 FNAB from the last 6 months 3. Normal serum calcitonin 4. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in thyroid nodule's volume | Month 6 |
Secondary
| Measure | 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 |
Countries
Bulgaria
Outcome results
None listed