HIFU in Patients With Non-malignant Thyroid Nodules

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

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

Study Overview

• Status: Completed
• Conditions: Non-malignant Thyroid Nodules
• Intervention / Treatment: Device: Echopulse

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Reggio Emilia, Italy, 42100
    • Istituto in tecnologie avanzate e modelli assistenziali in oncologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm	Device: Echopulse

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Theraclion
• Investigators: Principal Investigator: Andrea Frasoldati, Dr

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): October 13, 2015
• Study Completion (Actual): October 13, 2015

Study Registration Dates

• First Submitted: September 26, 2014
• First Submitted That Met QC Criteria: October 2, 2014
• First Posted (Estimate): October 7, 2014

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: HIFU/REG/NT