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

Theraclion20 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-malignant Thyroid Nodule

Interventions

HIFU treatmentDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Clinic of thyroid and metabolite bone disease of the Acad. of Ivan Penchev UDHATE - 2, Zdrave street

Sofia, Bulgaria

Outcomes

Primary Outcomes

Change from baseline in thyroid nodule's volume

Time frame: Month 6

Secondary Outcomes

Change from baseline in thyroid nodule's structure and vascularisation

Time frame: Month 6

Number of participants with adverse events

Time frame: D1, D7, M1, M3 and M6

Data from ClinicalTrials.gov

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