Clinical trial NCT02246504: Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
Official title: Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-malignant Thyroid Nodule
Lead sponsor: Theraclion
Sponsor class: INDUSTRY
First posted: 2014-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in thyroid nodule's volume
timeFrame: Month 6
Secondary outcomes:
measure: Change from baseline in thyroid nodule's structure and vascularisation
timeFrame: Month 6
measure: Number of participants with adverse events
timeFrame: D1, D7, M1, M3 and M6
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Clinic of thyroid and metabolite bone disease of the Acad. of Ivan Penchev UDHATE - 2, Zdrave street
Study officials:
name: Roussanka Kovatcheva, Prof.
role: PRINCIPAL_INVESTIGATOR
References: