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HIFU Ablation vs Fixed-dose RAI-131 Therapy in Moderate-sized Non-toxic MNG

NCT04009863 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2022-05-20

No results posted yet for this study

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.

Conditions

  • Non Toxic Multinodular Goiter
  • High Intensity Focused Ultrasound
  • RAI

Interventions

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

RADIATION

Radioactive iodine (Radioidine i131)

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

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Hung Hin Brian Lang, MBBS(Hons) · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2022-02-20
Completion
2022-04-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04009863 on ClinicalTrials.gov