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

Non-malignant Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246504
• Other study ID #: HIFU/BG/NT
• Status: Completed
• Phase: N/A
• Start date: October 9, 2012
• Est. completion date: March 7, 2017

Study information

• Verified date: September 2019
• Source: Theraclion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 7, 2017
• Est. primary completion date: March 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Non-malignant Thyroid Nodule
• Thyroid Diseases
• Thyroid Nodule

Intervention

Device:
• HIFU treatment

Locations

Country	Name	City	State
Bulgaria	Clinic of thyroid and metabolite bone disease of the Acad. of Ivan Penchev UDHATE - 2, Zdrave street	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Theraclion

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in thyroid nodule's volume		Month 6
Secondary	Change from baseline in thyroid nodule's structure and vascularisation		Month 6
Secondary	Number of participants with adverse events		D1, D7, M1, M3 and M6