HIFU in Patients With Non-malignant Thyroid Nodules
Conditions
Non-malignant Thyroid Nodules
Conditions: official terms
Thyroid Diseases - Thyroid Nodule
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Echopulse
Type: Device
Overall Status
Recruiting
Summary
Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 fine-needle aspiration biopsy (FNAB) from the last 6 months

3. Normal serum calcitonin

4. No history of neck irradiation

- Normal thyroid-stimulating hormone (TSH).

- Targeted nodule accessible and eligible to HIFU

- Absence of abnormal vocal cord mobility at laryngoscopy.

- Nodule diameter ≥ 10mm measured by ultrasound.

- Nodule volume inferior to 10 cc

- 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 the assigned analgesia/anaesthesia.
Location
Istituto in tecnologie avanzate e modelli assistenziali in oncologia
Reggio Emilia, Italy
Status: Recruiting
Contact: Petros Tsamatropoulos, Dr. - Petros.Tsamatropoulos@asmn.re.it
Start Date
July 2014
Sponsors
Theraclion
Source
Theraclion
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page