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OpenTrials
Completed

NCT Number: NCT02258347

HIFU in Patients With Non-malignant Thyroid Nodules

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto in tecnologie avanzate e modelli assistenziali in oncologia

Reggio Emilia, 42100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 fine-needle aspiration biopsy (FNAB) from the last 6 months
  • Normal serum calcitonin
  • 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.

Treatment and study plan

Echopulse

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Theraclion

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 7, 2014
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.