Treatment of Benign Thyroid Nodules With FastScan HIFU

Echopulse is specially designed, manufactured and CE marked for treating benign thyroid nodules. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.

In a previous european feasibility study performed at 1 site (Bulgaria), 20 benign thyroid nodules were treated. The HIFU treatment was well tolerated and showed efficacy.

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 (fine-needle aspiration biopsy) from the last 6 months
• Normal serum calcitonin
• No history of neck irradiation
• Normal TSH (thyroid-stimulating hormone)
• 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) : predominantly solid
• Patient has signed a written informed consent.

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.