search
Back to results

Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.

Primary Purpose

Non-malignant Thyroid Nodule

Status
Completed
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
HIFU treatment
Sponsored by
Theraclion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-malignant Thyroid Nodule

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinic of thyroid and metabolite bone disease of the Acad. of Ivan Penchev UDHATE - 2, Zdrave street

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIFU treatment

Arm Description

use of HIFU treatment in patients with non-malignant thyroid nodules

Outcomes

Primary Outcome Measures

Change from baseline in thyroid nodule's volume

Secondary Outcome Measures

Change from baseline in thyroid nodule's structure and vascularisation
Number of participants with adverse events

Full Information

First Posted
September 16, 2014
Last Updated
September 13, 2019
Sponsor
Theraclion
search

1. Study Identification

Unique Protocol Identification Number
NCT02246504
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 9, 2012 (Actual)
Primary Completion Date
March 7, 2017 (Actual)
Study Completion Date
March 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theraclion

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-malignant Thyroid Nodule

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIFU treatment
Arm Type
Experimental
Arm Description
use of HIFU treatment in patients with non-malignant thyroid nodules
Intervention Type
Device
Intervention Name(s)
HIFU treatment
Primary Outcome Measure Information:
Title
Change from baseline in thyroid nodule's volume
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Change from baseline in thyroid nodule's structure and vascularisation
Time Frame
Month 6
Title
Number of participants with adverse events
Time Frame
D1, D7, M1, M3 and M6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Non suspect clinically and at ultrasonography imaging Benign cytological diagnosis at FNAB from the last 6 months Normal serum calcitonin 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roussanka Kovatcheva, Prof.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of thyroid and metabolite bone disease of the Acad. of Ivan Penchev UDHATE - 2, Zdrave street
City
Sofia
ZIP/Postal Code
14031
Country
Bulgaria

12. IPD Sharing Statement

Learn more about this trial

Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.

We'll reach out to this number within 24 hrs