HIFU in Patients With Non-malignant Thyroid Nodules

Not Applicable

Completed

• Conditions: Non-malignant Thyroid Nodules
• Interventions: Device: Echopulse

• Registration Number: NCT02258347
• Lead Sponsor: Theraclion

Brief Summary

Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-10-02
• Study First Posted: 2014-10-07
• Primary Completion: 2015-10-13
• Study Completion: 2015-10-13
• Status Verified: 2018-05
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Echopulse	-

Primary Outcome Measures

Name	Time	Method
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
Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US)	Month 6 and Month 12

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events as a measure of safety and tolerability	Day 1, Month 1, Month 3, Month 6 and Month 12

Trial Locations

Locations (1)

Istituto in tecnologie avanzate e modelli assistenziali in oncologia; 🇮🇹 Reggio Emilia, Italy