CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 156 enrolled
Drug / intervention
Echopulse +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04009863
NCT04009863N/ACompleted

A Randomized, Open-label, Parallel-group Study to Determine the Efficacy of Sequential High-intensity Focused Ultrasound (HIFU) Ablation Versus Fixed-dose Radioiodine-131 Therapy in Moderate-sized Non-toxic Multinodular Goiter

The University of Hong Kong·interventional·Posted Jul 5, 2019·Updated May 20, 2022

In Brief

A clinical study evaluating Echopulse and Radioactive iodine (Radioidine i131) for Non Toxic Multinodular Goiter and 2 related conditions. Completed, enrolled 156 participants across 1 site.

Detailed Summary

After obtaining informed consent, eligible subjects will be assigned randomly into either High intensity focused ultrasound group (HIFU) or Radioactive iodine (131I) therapy group (RAIT). After treatment, they will be followed up for 4 visits (1-month, 3-month, 6- month, 12-month of post treatment). At each visit, they will have physical examination, regular blood test and questionnaire to evaluate their quality of life. The collected data will be used to compare the effectiveness between HIFU and RAIT for non-toxic multi-nodular goiter (NMNG). The primary purepose is to find out the best non-invasive way in treating NMNG. For HIFU, you may experience: 1. Mild bruising and redness at the site of treatment 2. Edema of the skin tissue 3. Pain/discomfort during the procedure 4. Skin burns but rare (\<1%) 5. Vocal cord paresis on the side of the treated lobe but rare (\<1%) 6. Unintentional damage to the surrounding tissue (outside the planned treatment area). For RAIT, you may experience neck tenderness or sore throat in the following few days as developing moderate inflammation in the thyroid and producing discomfort in the neck or throat area. Your symptoms may turn worse for first few week, but will improve over weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHong Kong
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 5, 2019
Enrollment StartApr 1, 2020
Primary CompletionFeb 20, 2022
Study CompletionApr 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.0 years ago

Interventions

Echopulsedevice

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

Radioactive iodine (Radioidine i131)radiation

Radioactive iodine (RAI) is a radioactive form of iodine that for ablation in thyroid disease (i.e. Graves' disease or few thyroid cancer)