## Protocol Section
### Identification Module
**NCT ID:** NCT06418919

**Brief Title:** A Prospective Evaluation of Radiofrequency Ablation in the Treatment of Relapsed Graves' Disease.

**Official Title:** A Prospective Evaluation of Radiofrequency Ablation in the Treatment of Relapsed Graves' Disease.

#### Organization Study ID Info
**ID:** UW 22-504
#### Organization
**Class:** OTHER
**Full Name:** The University of Hong Kong
### Status Module
#### Completion Date
**Date:** 2025-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-29

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The University of Hong Kong

#### Responsible Party

**Investigator Affiliation:** The University of Hong Kong

**Investigator Full Name:** Dr. Lang Hung Hin, Brian

**Investigator Title:** Clinical Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** There have been previous reports of using High-intensity focused ultrasound (HIFU) as a feasible thermal ablative treatment for relapsed Graves' disease. In recent years, radiofrequency ablation (RFA) has become another promising alternative for thermal ablation of benign thyroid nodules. RFA has the advantage of avoiding a surgical scar, organ preservation and being an ambulatory procedure. It utilizes a small caliber radiofrequency electrode, which is inserted into the thyroid gland percutaneously. The active tip of the RF electrode would induce frictional heat in the surrounding tissue, causing a thermal ablative effect. The direct application of energy of RFA to tissue is different from that in HIFU, in which energy is transmitted through the skin of the participants from the transducer.

Studies of follow-up after RFA of Graves' disease have not been published. Given the previous successful experience with HIFU, the investigators would like to explore the feasibility, safety and efficacy of RFA as an alternative thermal ablation option for relapsed Graves' disease. Thus, the purpose of this prospective study is to assess the efficacy and safety of US-guided RFA for the treatment of relapsed Graves' disease.

### Conditions Module

**Conditions:**

- Relapsed Graves' Disease

- Thyroid; Functional Disturbance

- Radiofrequency Ablation Treatment

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: Radiofrequency ablation treatment

**Label:** RFA treatment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- RFA treatment

**Description:** RFA is used to ablate the entire thyroid gland

**Name:** Radiofrequency ablation treatment

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Graves' disease remission rate after a single course of RFA

**Measure:** Short term disease remission rate after a single course of RFA

**Time Frame:** 12 months

**Description:** Graves' disease remission after a single course of RFA

**Measure:** Mid term remission rate after a single course of RFA

**Time Frame:** 24 months and 36 months

**Description:** To measure the complication rates after RFA

**Measure:** Complication rates

**Time Frame:** 1 month

**Description:** To examine the change in qualitfy of life with SF-12 scores in post-treatment from baseline to 24 months and 36 months

**Measure:** Change in Quality of life

**Time Frame:** 24 months, 36 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hong Kong

**Country:** Hong Kong

**Facility:** Queen Mary Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** The University of Hong Kong

**Name:** Matrix, Man Him Fung, MBBS

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Cooper DS. Antithyroid drugs. N Engl J Med. 2005 Mar 3;352(9):905-17. doi: 10.1056/NEJMra042972. No abstract available.

**PMID:** 15745981

**Citation:** Watanabe N, Narimatsu H, Noh JY, Yamaguchi T, Kobayashi K, Kami M, Kunii Y, Mukasa K, Ito K, Ito K. Antithyroid drug-induced hematopoietic damage: a retrospective cohort study of agranulocytosis and pancytopenia involving 50,385 patients with Graves' disease. J Clin Endocrinol Metab. 2012 Jan;97(1):E49-53. doi: 10.1210/jc.2011-2221. Epub 2011 Nov 2.

**PMID:** 22049174

**Citation:** Yip J, Lang BH, Lo CY. Changing trend in surgical indication and management for Graves' disease. Am J Surg. 2012 Feb;203(2):162-7. doi: 10.1016/j.amjsurg.2011.01.029. Epub 2011 Jun 17.

**PMID:** 21683939

**Citation:** Lang BH, Woo YC, Chiu KW. Two-year outcomes of single-session high-intensity focused ultrasound (HIFU) treatment in persistent or relapsed Graves' disease. Eur Radiol. 2019 Dec;29(12):6690-6698. doi: 10.1007/s00330-019-06303-8. Epub 2019 Jun 17.

**PMID:** 31209622

**Citation:** Lang BH, Woo YC, Wong IY, Chiu KW. Single-Session High-Intensity Focused Ultrasound Treatment for Persistent or Relapsed Graves Disease: Preliminary Experience in a Prospective Study. Radiology. 2017 Dec;285(3):1011-1022. doi: 10.1148/radiol.2017162776. Epub 2017 Jul 20.

**PMID:** 28727542

**Citation:** Kim JH, Baek JH, Lim HK, Ahn HS, Baek SM, Choi YJ, Choi YJ, Chung SR, Ha EJ, Hahn SY, Jung SL, Kim DS, Kim SJ, Kim YK, Lee CY, Lee JH, Lee KH, Lee YH, Park JS, Park H, Shin JH, Suh CH, Sung JY, Sim JS, Youn I, Choi M, Na DG; Guideline Committee for the Korean Society of Thyroid Radiology (KSThR) and Korean Society of Radiology. 2017 Thyroid Radiofrequency Ablation Guideline: Korean Society of Thyroid Radiology. Korean J Radiol. 2018 Jul-Aug;19(4):632-655. doi: 10.3348/kjr.2018.19.4.632. Epub 2018 Jun 14.

**PMID:** 29962870

**Citation:** Kuo JH, Lee JA. The Adoption of Ultrasound-guided Radiofrequency Ablation of Thyroid Nodules in the United States. Ann Surg. 2021 Jan 1;273(1):e10-e12. doi: 10.1097/SLA.0000000000003930. No abstract available.

**PMID:** 33064390

**Citation:** Papini E, Pacella CM, Solbiati LA, Achille G, Barbaro D, Bernardi S, Cantisani V, Cesareo R, Chiti A, Cozzaglio L, Crescenzi A, De Cobelli F, Deandrea M, Fugazzola L, Gambelunghe G, Garberoglio R, Giugliano G, Luzi L, Negro R, Persani L, Raggiunti B, Sardanelli F, Seregni E, Sollini M, Spiezia S, Stacul F, Van Doorne D, Sconfienza LM, Mauri G. Minimally-invasive treatments for benign thyroid nodules: a Delphi-based consensus statement from the Italian minimally-invasive treatments of the thyroid (MITT) group. Int J Hyperthermia. 2019;36(1):376-382. doi: 10.1080/02656736.2019.1575482. Epub 2019 Mar 26.

**PMID:** 30909759

#### See Also Links

**Label:** Ultrasound-guided percutaneous radiofrequency ablation for benign thyroid nodules

**URL:** http://www.nice.org.uk/guidance/ipg562

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005094

- Term: Exophthalmos

- ID: D000009916

- Term: Orbital Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000006042

- Term: Goiter

- ID: D000013959

- Term: Thyroid Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000006980

- Term: Hyperthyroidism

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M16718

- Name: Thyroid Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9214

- Name: Graves Disease

- Relevance: HIGH

- As Found: Graves' Disease

- ID: M8237

- Name: Exophthalmos

- Relevance: LOW

- As Found: Unknown

- ID: M12845

- Name: Orbital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9147

- Name: Goiter

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10031

- Name: Hyperthyroidism

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006111

- Term: Graves Disease

### Misc Info Module

- Version Holder: 2024-05-31
