HIFU Reapplication in Benign Nodules

October 9, 2018 updated by: Dr. Lang Hung Hin, Brian, The University of Hong Kong

Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Reapplication in Benign Thyroid Nodules That Had Less-than Adequate Shrinkage Following Single-session HIFU Treatment.

High Intensity Focused Ultrasound (HIFU) is a new approach in treating benign thyroid nodule without surgery. It is proven effective and safe relative to traditional surgery. From previous HIFU studies, it caused shrinkage of thyroid nodule up to 70% from original size. Unfortunately, 5-10% of nodule do not shrink. Those which do not shrink are usually large in size and therefore a second HIFU treatment may help. This study is going to evaluate the efficacy and safety of reapplication HIFU after the first single HIFU session in 6 months.

The study will be carried out in the following steps:

  1. Recruit subject from the clinic according to the study criteria.
  2. Arrange the reapplication HIFU treatment within 3 months.
  3. Arrange 4 visits after the HIFU treatment in Post 7 days, Post 1 month, Post 3 months, and Post 6 months; Data collection will be in these 4 visits through the questionnaire or interview by research assistant
  4. The subjects will have further health management with the same team after the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thyroid nodules are common and although most are benign and remain relatively static in size, some can grow and become large and cause local symptoms over time. In such scenario, thyroidectomy is usually indicated. However, surgery is not only associated with complications but also with high cost and general anesthesia. As a result, there has been a growing interest in exploring less invasive, non-surgical technique for benign thyroid nodules. For solid or predominantly-solid (<30% cystic areas) thyroid nodules, thermal ablation techniques have been shown to be highly effective in causing nodule shrinkage and alleviating symptoms in the long-term. To date, numerous thermal ablation techniques have been described and they include radiofrequency ablation (RFA), percutaneous laser ablation (PLA), microwave ablation and more recently, high intensity focused ultrasound (HIFU). HIFU is now considered the least invasive technique as there is no need for needle insertion into the target lesion during treatment. It works by utilizing focused ultrasound energy to generate heat and induce thermal ablation beneath the skin and other tissue layers. Recent studies (including several from our group) have shown that it is effective in not only inducing significant nodule shrinkage but also in alleviating nodule-related symptoms.

However, despite its overall success, approximately 10 - 15% of solid or predominantly solid nodules do not shrink adequately (i.e. <50% shrinkage from baseline in the first 6-12 months). Although the exact reason why some nodules do not respond remains unclear, it is noted that the majority of these less responsive nodules are larger in size / volume and so, a second or reapplication of ablation might be required to cause further shrinkage and improvement in symptoms [11]. However, the role of HIFU reapplication in nodules with less-than-adequate response (<50% at 6 months) remains undefined. As a result, the present study is aimed to the feasibility and safety of HIFU reapplication in nodules with shrinkage <50% of baseline volume 6 months after single-session HIFU treatment.

Study Type

Interventional

Enrollment (Actual)

28

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

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients age older than 18 years,
  • a nodule that has previously been completely treated by single-session HIFU ablation but has not responded adequately (i.e. <50% volume reduction from baseline after 6 months),
  • a benign nodule without signs of malignancy (e.g, nonsuspicious clinical and US appearance, benign results at cytologic examination performed in the last 6 months, normal serum calcitonin level),
  • a nodule measuring on US greater than or equal to 10 mm in three orthogonal dimensions,
  • less than 30% of the targeted nodule comprising cystic area,
  • HIFU accessibility of the targeted nodule (distance between the skin and the anterior surface of the nodule less than 17 mm, with no interference of the collarbone with HIFU unit movements)
  • normal thyrotropin concentration and
  • absence of vocal cord immobility at laryngoscopy.

Exclusion Criteria:

  • head and/or neck disease preventing hyperextension of the neck,
  • history of thyroid cancer or other malignant tumors in the neck region,
  • history of neck irradiation,
  • intranodular macrocalcifications inducing a shadow substantial enough to preclude treatment with HIFU,
  • nodules next to the posterior margin of the thyroid lobe with anteroposterior diameter less than 15 mm,
  • pregnancy or lactation,
  • any contraindication related to intravenous moderate sedation in the first HIFU treatment.

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: High Intensity Focused Ultrasound
Device: Echopulse
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
Other Names:
  • High Intensity Focused Ultrasound (HIFU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in thyroid nodule volume (mL)
Time Frame: 6 months
To measure the change in volume (mL) of the index (or treated) thyroid nodule 6 months following HIFU reapplication
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of reapplication HIFU after the first single session in 6 months
Time Frame: 6 months
To compare the change in volume (mL) of the treated thyroid nodule between the first single session and the reapplication.
6 months
The safety of reapplication HIFU after the first single session in 6 months
Time Frame: 6 months
To assess the safety of reapplication HIFU by recording any complications after the treatment
6 months
The rate of vocal cord palsy in reapplication HIFU after the first single session in 6 months
Time Frame: 6 months
To examine the rate of vocal cord palsy in reapplication HIFU after the first single session in 6 month
6 months
The cosmetic score (in 0-10) of reapplication HIFU after the first single session in 6 months
Time Frame: 6 months
To evaluate the cosmetic score (in 0-10) of reapplication HIFU after the first single session in 6 months
6 months
The pain score (in 0-10) of reapplication HIFU after the first single session in 6 months
Time Frame: 6 months
To evaluate the pain score (in 0-10) of reapplication HIFU after the first single session in 6 month
6 months
The satisfactory (in 0-10) of reapplication HIFU after the first single session in 6 month
Time Frame: 6 months
The satisfactory level, from scoring in 0-10, to examine how participants' satisfaction in the reapplication HIFU after the first single session in 6 months
6 months

Collaborators and Investigators

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

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Hung Hin, Brian Lang, MBBS (Hons), The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

August 30, 2018

Study Registration Dates

First Submitted

October 27, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 17-234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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