Clinical trial NCT02491502: Treatment of Benign Thyroid Nodules With FastScan HIFU
Official title: Treatment of Benign Thyroid Nodules With FastScan High Intensity Focused Ultrasound (HIFU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Thyroid Nodules
Lead sponsor: Theraclion
Sponsor class: INDUSTRY
First posted: 2015-07-08
Enrollment: 36
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: This study evaluates the efficacy of the HIFU for the treatment of benign thyroid nodules with the FastScan version using assessment of patient experience and adverse event reporting.

Detailed description: Echopulse is specially designed, manufactured and CE marked for treating benign thyroid nodules. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.

In a previous european feasibility study performed at 1 site (Bulgaria), 20 benign thyroid nodules were treated. The HIFU treatment was well tolerated and showed efficacy.

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 (fine-needle aspiration biopsy) from the last 6 months
  3. Normal serum calcitonin
  4. No history of neck irradiation
* Normal TSH (thyroid-stimulating hormone)
* 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) : predominantly solid
* Patient has signed a written informed consent.

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.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 1 day post treatment
measure: Number of participants with adverse events
timeFrame: 3 days post treatment
measure: Number of participants with adverse events
timeFrame: 7 days post treatment
measure: Change in volume of the thyroid nodule compared to Baseline at 6 months
timeFrame: 6 months post treatment
measure: Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day
timeFrame: 1 day post treatment
measure: Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days
timeFrame: 3 days post treatment
measure: Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days
timeFrame: 7 days post treatment
measure: Patient satisfaction questionnaire
timeFrame: 6 months post treatment
Secondary outcomes:
measure: Number of patients with Absence of palpable lesion
timeFrame: 3 months post treatment
measure: Number of patients with Absence of palpable lesion
timeFrame: 6 months post treatment
measure: Patient Cosmetic evaluation measured by questionnaire
timeFrame: 6 months post treatment
measure: Investigator rated evaluation of the device
timeFrame: Post treatment Day 0
measure: Change from Baseline of gland vascularization at 3 months
timeFrame: 3 months post treatment
measure: Change from Baseline of gland vascularization at 6 months
timeFrame: 6 months post treatment
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: University Hospital of Endocrinology USBALE
Study officials:
affiliation: roussanka_kov@yahoo.com
name: Roussanka Kovatcheva, Prof.
role: PRINCIPAL_INVESTIGATOR
References: