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

Not Applicable

Completed

• Conditions: Non-malignant Thyroid Nodule
• Interventions: Device: HIFU treatment

• Registration Number: NCT02246504
• Lead Sponsor: Theraclion

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

Study Timeline

• Study Start: 2012-10-09
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-22
• Primary Completion: 2017-03-07
• Study Completion: 2017-03-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-13
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIFU treatment	HIFU treatment	use of HIFU treatment in patients with non-malignant thyroid nodules

Primary Outcome Measures

Name	Time	Method
Change from baseline in thyroid nodule's volume	Month 6

Secondary Outcome Measures

Name	Time	Method
Change from baseline in thyroid nodule's structure and vascularisation	Month 6
Number of participants with adverse events	D1, D7, M1, M3 and M6

Trial Locations

Locations (1)

Clinic of thyroid and metabolite bone disease of the Acad. of Ivan Penchev UDHATE - 2, Zdrave street; 🇧🇬 Sofia, Bulgaria