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HIFU in Patients With Non-malignant Thyroid Nodules

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ClinicalTrials.gov Identifier: NCT02258347
Recruitment Status : Terminated (End of recruitment period - study recruitment objectives not reached)
First Posted : October 7, 2014
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Theraclion

Brief Summary:
Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.

Condition or disease Intervention/treatment Phase
Non-malignant Thyroid Nodules Device: Echopulse Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
Actual Study Start Date : July 2014
Actual Primary Completion Date : October 13, 2015
Actual Study Completion Date : October 13, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arm Intervention/treatment
Experimental: Single arm Device: Echopulse



Primary Outcome Measures :
  1. Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US) [ Time Frame: Month 6 and Month 12 ]
  2. Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US) [ Time Frame: Month 6 and Month 12 ]
  3. Evaluation of thyroid nodule's vascularisation changes following HIFU therapy assessed by ultrasonography (US) [ Time Frame: Month 6 and Month 12 ]

Secondary Outcome Measures :
  1. Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Day 1, Month 1, Month 3, Month 6 and Month 12 ]


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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 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.

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): NCT02258347


Locations
Italy
Istituto in tecnologie avanzate e modelli assistenziali in oncologia
Reggio Emilia, Italy, 42100
Sponsors and Collaborators
Theraclion
Investigators
Principal Investigator: Andrea Frasoldati, Dr

Responsible Party: Theraclion
ClinicalTrials.gov Identifier: NCT02258347     History of Changes
Other Study ID Numbers: HIFU/REG/NT
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms