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NCT Number: NCT06506149

A Prospective Evaluation of Microwave Ablation (MWA) in the Treatment of Relapsed Graves' Disease

Graves' disease is the most common cause of hyperthyroidism, with conventional treatment options being anti-thyroid drugs (ATD), radioiodine (RAI) and surgery. For ATD, it has been the first-line treatment over decades. Despite its ability to induce remission, minor side effects such as skin rash, gastrointestinal disturbance and arthralgia occur in around 5% of patients, while serious adverse reactions including agranulocytosis and hepatotoxicity are potentially life threatening. Patients are usually treated with ATD for 12 to 18 months but the relapse rate was reported to be up to 50-60% which these patients would require more definitive treatment options with RAI or thyroidectomy. However, RAI is not preferable in patients with Graves' ophthalmopathy as it could further worsen eye symptoms. RAI may also cause hypothyroidism in a substantial proportion of patients, with a subsequent need for lifelong thyroxine replacement. As for thyroidectomy, it carries an overall 2-10% risk of complications including bleeding, transient or permanent recurrent laryngeal nerve injury and hypoparathyroidism. Due to the drawbacks of the various conventional treatment options, there has been increasing interest in the development of minimally invasive treatment alternatives in recent years. With the evolution of thermal ablative strategies, high-intensity focused ultrasound (HIFU) and radiofrequency ablation (RFA) have been reported as feasible treatment options for relapsed Graves' disease. There has also been increasing reports in the use of microwave ablation (MWA) in the treatment of benign thyroid nodules. MWA works via generation of electromagnetic field and is performed by inserting a microwave antenna into the thyroid gland percutaneously under ultrasound (USG) guidance. The active tip of the antenna causes oscillation of the surrounding water molecules which induces frictional heat and creates a thermal ablative effect. As compared to RFA, MWA is not affected by heat sink effect and may require a shorter treatment time. Similar to other thermal ablative approaches, MWA has the merits of avoiding surgical scar, organ preservation as well as being an ambulatory procedure.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong, 00000

Location status: Recruiting

Location contact

Man Him, Matrix Fung, MBBS

CONTACT

[email protected]

+852-22554232

Man Him, Matrix Fung, MBBS

PRINCIPAL_INVESTIGATOR

Yan Luk, MBBS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • (a) age older than 18 years,
  • (b) relapsed Graves' disease despite an adequate ATD treatment for 18 months or more
  • (c) absence of vocal cord immobility

Exclusion criteria

  • (a) patients who prefer or are indicated for surgery,
  • (b) presence of head and/or neck disease preventing hyperextension of the neck,
  • (c) history of thyroid cancer or other malignant tumours in the neck region,
  • (d) history of neck irradiation,
  • (e) severe Graves' ophthalmopathy,
  • (f) large compressive goitre,
  • (g) pregnancy or lactation, and
  • (h) any contraindication to intravenous sedation.

Treatment and study plan

Microwave ablation(MWA) device

Device

The device for USG-guided MWA treatment would be performed under USG guidance, aiming to ablate the entire thyroid gland, i.e. the right lobe, left lobe, isthmus and pyramidal lobe.

Primary outcomes

  1. To measure the remission rate of Graves' disease at 6-months post-procedure

    Time frame: 6 months

    To measure the remission rate of Graves' disease at 6-months post-procedure

Secondary outcomes

  1. Change of quality of life by SF12 ver 2

    Time frame: 6 months

    SF-12(v2) is an assessment tool about quality of life. It comprises 12 question items ranging from 11 (worst quality of life) to 56 (best quality of life).

  2. To measure the percentage of volume change

    Time frame: 6 months

    the percentage of volume change would be calculated as: ([Volbasal - Volfinal] · 100)/Volbasal.

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Luk, MBBS

CONTACT

[email protected]

+852 2255 4232

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 17, 2024
Registry last updated
Jul 29, 2024

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.

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