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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02246504
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Theraclion

Brief Summary:
The purpose of this study is to evaluate thyroid nodule's volume, structure and vascularisation changes following HIFU therapy assessed by ultrasonography

Condition or disease Intervention/treatment Phase
Non-malignant Thyroid Nodule Device: HIFU treatment Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
Actual Study Start Date : October 9, 2012
Actual Primary Completion Date : March 7, 2017
Actual Study Completion Date : March 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

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



Primary Outcome Measures :
  1. Change from baseline in thyroid nodule's volume [ Time Frame: Month 6 ]

Secondary Outcome Measures :
  1. Change from baseline in thyroid nodule's structure and vascularisation [ Time Frame: Month 6 ]
  2. Number of participants with adverse events [ Time Frame: D1, D7, M1, M3 and M6 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246504


Locations
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Bulgaria
Clinic of thyroid and metabolite bone disease of the Acad. of Ivan Penchev UDHATE - 2, Zdrave street
Sofia, Bulgaria, 14031
Sponsors and Collaborators
Theraclion
Investigators
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Principal Investigator: Roussanka Kovatcheva, Prof.

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Responsible Party: Theraclion
ClinicalTrials.gov Identifier: NCT02246504    
Other Study ID Numbers: HIFU/BG/NT
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Thyroid Nodule
Thyroid Diseases
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms