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

September 13, 2019 updated by: Theraclion
The purpose of this study is to evaluate thyroid nodule's volume, structure and vascularisation changes following HIFU therapy assessed by ultrasonography

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 14031
        • Clinic of thyroid and metabolite bone disease of the Acad. of Ivan Penchev UDHATE - 2, Zdrave street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIFU treatment
use of HIFU treatment in patients with non-malignant thyroid nodules
Device: HIFU treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in thyroid nodule's volume
Time Frame: Month 6
Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in thyroid nodule's structure and vascularisation
Time Frame: Month 6
Month 6
Number of participants with adverse events
Time Frame: D1, D7, M1, M3 and M6
D1, D7, M1, M3 and M6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theraclion

Investigators

  • Principal Investigator: Roussanka Kovatcheva, Prof.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2012

Primary Completion (Actual)

March 7, 2017

Study Completion (Actual)

March 7, 2017

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIFU/BG/NT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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