A Prospective Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Benign Thyroid Nodules

NCT02658552 | Completed DMC

• 1 other identifier: UW15-486
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the short-term efficacy of high intensity focused ultrasound (HIFU) in the treatment of benign thyroid nodules

Conditions

Benign Thyroid Nodules

Keywords

HIFU; Benign thyroid nodule; Low risk; New treatment

Outcome Measures

Primary Outcomes (2)

• The changing volume of benign thyroid nodule after HIFU treatment

  Change in volume (ml) of the targeted benign thyroid nodule 6 months after one successful course of HIFU

  6 months

• The changing greatest dimension of benign thyroid nodule after HIFU treatment

  Change in greatest dimension (in mm) of the targeted benign thyroid nodule 6 months after one successful course of HIFU

  6 months

Secondary Outcomes (2)

• The pain assessment (scoring 1-10) after treatment

  6 months

• Incidence of local/ or general adverse events

  6 months

Study Arms (1)

HIFU treatment

EXPERIMENTAL

To collect the data after HIFU treatment

Device: Echopulse

Interventions

Echopulse DEVICE

Echopulse is a real-time US-guided High-intensity focused ultrasound (HIFU) system, the HIFU session is a noninvasive procedure that involves application of a focused high-energy ultrasound beam for thermal tissue ablation inside the targeted zone, with minimal effect on the surrounding tissue

HIFU treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient 18 years or older.
• Patient presenting with at least one thyroid nodule with no signs of malignancy:
• Non suspicious clinically and at ultrasonography imaging
• Benign cytological diagnosis at fine needle aspiration biopsy in the last 6 months
• Normal serum calcitonin
• No history of neck irradiation
• Serum TSH and free T4 levels within the normal range
• Targeted nodule deemed to be accessible and eligible to HIFU
• Absence of vocal cord paresis at laryngoscopy
• Nodule greatest diameter between ≥10 - 20mm as measured by ultrasound
• Composition of the targeted nodule(s) : predominantly solid
• Patient is mentally competent and has given informed consent.

You may not qualify if:

• Head and/or neck disease that prevents extension of neck
• Known history of thyroid cancer or other malignant tumors in the neck region
• History of neck irradiation
• Intranodular macrocalcification inducing a shadow in the thyroid significant enough to preclude HIFU treatment
• A nodule next to the posterior margin of the lobe with distance \<15mm
• Pregnant or lactating woman
• Any contraindication to the assigned analgesia/anaesthesia.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (16)

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• Kovatcheva RD, Vlahov JD, Shinkov AD, Borissova AM, Hwang JH, Arnaud F, Hegedus L. High-intensity focused ultrasound to treat primary hyperparathyroidism: a feasibility study in four patients. AJR Am J Roentgenol. 2010 Oct;195(4):830-5. doi: 10.2214/AJR.09.3932.

  PMID: 20858805 BACKGROUND

• Kovatcheva RD, Vlahov JD, Stoinov JI, Kirilov GG, Krivoshiev SG, Arnaud F, Ortuno C, Drueke TB. High-intensity focussed ultrasound (HIFU) treatment in uraemic secondary hyperparathyroidism. Nephrol Dial Transplant. 2012 Jan;27(1):76-80. doi: 10.1093/ndt/gfr590. Epub 2011 Oct 19.

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• Kovatcheva R, Vlahov J, Stoinov J, Lacoste F, Ortuno C, Zaletel K. US-guided high-intensity focused ultrasound as a promising non-invasive method for treatment of primary hyperparathyroidism. Eur Radiol. 2014 Sep;24(9):2052-8. doi: 10.1007/s00330-014-3252-4. Epub 2014 Jun 4.

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Study Officials

• Hung Hin, Brian Lang, MBBS(Hons)

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 20, 2016
• Study Start: October 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

HK (1)