Non-malignant Thyroid Nodules Clinical Trial
Official title:
Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
| NCT number | NCT02258347 |
| Other study ID # | HIFU/REG/NT |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 2014 |
| Est. completion date | October 13, 2015 |
| Verified date | May 2018 |
| Source | Theraclion |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.
| Status | Completed |
| Enrollment | 4 |
| Est. completion date | October 13, 2015 |
| Est. primary completion date | October 13, 2015 |
| 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 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. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Istituto in tecnologie avanzate e modelli assistenziali in oncologia | Reggio Emilia |
| Lead Sponsor | Collaborator |
|---|---|
| Theraclion |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US) | Month 6 and Month 12 | ||
| Primary | Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US) | Month 6 and Month 12 | ||
| Primary | Evaluation of thyroid nodule's vascularisation changes following HIFU therapy assessed by ultrasonography (US) | Month 6 and Month 12 | ||
| Secondary | Number of subjects with adverse events as a measure of safety and tolerability | Day 1, Month 1, Month 3, Month 6 and Month 12 |