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

Theraclion

Status

Completed

Conditions

Non-malignant Thyroid Nodule

Treatments

Device: HIFU treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT02246504

HIFU/BG/NT

Details and patient eligibility

About

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

Full 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

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.