Overview

This trial is active, not recruiting.

Condition non-malignant thyroid nodule
Treatment hifu treatment
Sponsor Theraclion
Start date December 2012
End date July 2017
Trial size 10 participants
Trial identifier NCT02246504, HIFU/BG/NT

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
use of HIFU treatment in patients with non-malignant thyroid nodules
hifu treatment

Primary Outcomes

Measure
Change from baseline in thyroid nodule's volume
time frame: Month 6

Secondary Outcomes

Measure
Change from baseline in thyroid nodule's structure and vascularisation
time frame: Month 6
Number of participants with adverse events
time frame: D1, D7, M1, M3 and M6

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
Principal investigator Roussanka Kovatcheva, Prof.
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 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Theraclion.