Thyroid Nodule \(Benign\)NCT06426563
MWA vs RFA for the Treatment of Moderate-sized Benign Thyroid Nodules
A study testing Ablation treatment of thyroid nodule in people with Thyroid Nodule \(Benign\) and Ablation Therapy, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Thyroid nodule is a common condition that affects up to 60% of the population. There is an estimated 10% lifetime probability of developing a thyroid nodule. Although most thyroid nodules are benign, up to 10-15% can enlarge to cause compressive symptoms including neck pressure and discomfort, dysphagia, dyspnea, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule \(Benign\), Ablation Therapy
- What is being tested?
- Ablation treatment of thyroid nodule
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Apr 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients \>/=18 years of age
- Nodule maximal diameter ≥2cm and nodule volume \<20ml
- Nodule being predominantly solid (≥80% solid)
- Confirmed benign nature of nodules, either by : two benign fine needle biopsies, with the most recent biopsy performed within 1 year of enrollment in study or one benign fine needle biopsy and low suspicion characteristics on ultrasound
- Both functional and non-functional nodules are eligible.
Who cannot join
- Cytologically indeterminate nodules
- Nodules with substernal extension or posterior extension that cannot be viewed sufficiently with ultrasound
- current pregnancy or cardiac arrhythmias; presence of pacemaker or any medical condition that renders patient unfit for thermal ablation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong, Hong Kong, 00000
Man Him, Matrix Fung, MBBS, +852-22554232, mmhfung@hku.hk
Man Him, Matrix Fung, MBBS
About this study
Official title: Microwave Ablation Versus Radiofrequency Ablation for the Treatment of Moderate-sized Benign Thyroid Nodules, a Randomized Controlled Trial
Thyroid nodule is a common condition that affects up to 60% of the population. There is an estimated 10% lifetime probability of developing a thyroid nodule. Although most thyroid nodules are benign, up to 10-15% can enlarge to cause compressive symptoms including neck pressure and discomfort, dysphagia, dyspnea, and dysphonia. The conventional treatment for these benign but problematic nodules has been thyroidectomy. Although generally a low risk operation, thyroidectomy is associated with some risk for recurrent laryngeal nerve injury, bleeding, infection, and need for thyroid hormone supplementation. Since the early 2000s, ultrasound-guided percutaneous thermal ablation has emerged as a potential alternative treatment to surgery for benign thyroid nodules. Of the myriad ablation methods, the most commonly used techniques are radiofrequency ablation (RFA) and microwave ablation (MWA). [1-3] A growing body of evidence shows that RFA is an effective treatment for benign solid thyroid nodules, toxic adenomas, and thyroid cysts resulting in overall volume reduction ranges of 40-80% at 1 year, with durable resolution of compressive and hyperthyroid symptoms. However, RFA is not without its limitations. Radiofrequency waves can be limited by the heat sink effect and tissue char leading to longer procedure times and potentially less optimal outcomes in larger, hypervascular, and/or more cystic nodules.
Microwave ablation (MWA) is another ablative technique that uses electromagnetic energy waves to cause tissue hyperthermia and coagulative necrosis. It generally causes higher ablation temperatures than RFA and is less subject to the heat sink effect, and therefore can facilitate more efficient ablation procedures. Current evidence comparing RFA versus MWA for thyroid ablation was limited and was either retrospective, non-randomized [4-9], under-powered, or with an unequal baseline. The results from these studies were also conflicting, suggesting suboptimal quality of evidence and bias due to non-standardized technique of ablation across studies. To date, there is no randomized controlled trial comparing the efficacy and safety of RFA versus MWA for the treatment of benign thyroid nodules. Given the higher ablation temperatures, freedom from heat sink effect, and no influence from impedance changes during ablation, MWA may achieve different treatment efficacy.
- Conditions
- Thyroid Nodule \(Benign\), Ablation Therapy
- Being tested
- Ablation treatment of thyroid nodule
- Keywords
- Ablation therapy, Thyroid nodule, benign, RFA, MWA
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation treatment of thyroid noduleProcedure or surgery
Use Radiofrequency or Microwave ablation device to treat thyroid nodule
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation treatment (RFA) to thyroid nodule | Active comparator | Participants who are undergo thyroid nodule treatment by RFA Receives: Procedure: Ablation treatment of thyroid nodule |
| Microwave ablation treatment (MWA) to thyroid nodule | Active comparator | Participants who are undergo thyroid nodule treatment by MWA Receives: Procedure: Ablation treatment of thyroid nodule |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the volume reduction ratio (VRR) of the first ablated nodule at each procedure at 12-months post-procedure
Measured: 12 months
Secondary outcomes (7)
To measures nodule recurrence rate
Measured: 12-24 months
To measures thyroid nodule regrowth rate
Measured: 12-24 months
To measure cosmetic score by investigator (1-4)
To measure cosmetic score from 1 to 4 (1 is No palpable goitre, 2 is Palpable goitre but invisible, 3 is Goitre only visible to experienced clinician, 4 is Easily visible goitre)
Measured: 12-24 months
To measure the compressive symptom scores (from 0 - 100)
compressive symptom score from 0 (no compression feeling) to 100 (the most compressive)
Measured: 12-24 months
To measure swallowing impairment scores by questionnaire (SIS-6)
Swallowing Impairment Index (SIS-6) is an assessment tool about swallowing dysfunction and symptom. It comprises six question items ranging from 0 (no impairment) to 24 (maximum impairment)
Measured: 12-24 months
To measure pain score (0-10) after ablation treatment
0 is no pain, 10 is the most painful
Measured: 12-24 months
Change of quality of life by SF12 ver 2
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).
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start15 Apr 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Thyroid Nodule \(Benign\)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group is for radiofrequency ablation treatment (RFA), another group is for microwave ablation treatment (MWA)
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Man Him Matrix Fung, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426563
- Sponsor's protocol ID
- UW 24-141
- Status last verified
- Sep 2026
- First submitted
- 17 May 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lang BHH, Fung MMH. Safety and Efficacy of Single-Session Radiofrequency Ablation Treatment for Benign Non-toxic Multinodular Goiter. World J Surg. 2022 Jul;46(7):1704-1710. doi: 10.1007/s00268-022-06527-8. Epub 2022 Mar 21.
PubMed 35313358Cheng Z, Che Y, Yu S, Wang S, Teng D, Xu H, Li J, Sun D, Han Z, Liang P. US-Guided Percutaneous Radiofrequency versus Microwave Ablation for Benign Thyroid Nodules: A Prospective Multicenter Study. Sci Rep. 2017 Aug 25;7(1):9554. doi: 10.1038/s41598-017-09930-7.
PubMed 28842651Wu W, Gong X, Zhou Q, Chen X, Chen X. Ultrasound-Guided Percutaneous Microwave Ablation for Solid Benign Thyroid Nodules: Comparison of MWA versus Control Group. Int J Endocrinol. 2017;2017:9724090. doi: 10.1155/2017/9724090. Epub 2017 Nov 23.
PubMed 29333159He L, Zhao W, Xia Z, Su A, Li Z, Zhu J. Comparative efficacy of different ultrasound-guided ablation for the treatment of benign thyroid nodules: Systematic review and network meta-analysis of randomized controlled trials. PLoS One. 2021 Jan 20;16(1):e0243864. doi: 10.1371/journal.pone.0243864. eCollection 2021.
PubMed 33471820Hu K, Wu J, Dong Y, Yan Z, Lu Z, Liu L. Comparison between ultrasound-guided percutaneous radiofrequency and microwave ablation in benign thyroid nodules. J Cancer Res Ther. 2019;15(7):1535-1540. doi: 10.4103/jcrt.JCRT_322_19.
PubMed 31939434Guo DM, Chen Z, Zhai YX, Su HH. Comparison of radiofrequency ablation and microwave ablation for benign thyroid nodules: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2021 Jul;95(1):187-196. doi: 10.1111/cen.14438. Epub 2021 Mar 2.
PubMed 33556187Jin H, Fan J, Lu L, Cui M. A Propensity Score Matching Study Between Microwave Ablation and Radiofrequency Ablation in Terms of Safety and Efficacy for Benign Thyroid Nodules Treatment. Front Endocrinol (Lausanne). 2021 Mar 9;12:584972. doi: 10.3389/fendo.2021.584972. eCollection 2021.
PubMed 33767666Kim 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.
PubMed 29962870Huh JY, Baek JH, Choi H, Kim JK, Lee JH. Symptomatic benign thyroid nodules: efficacy of additional radiofrequency ablation treatment session--prospective randomized study. Radiology. 2012 Jun;263(3):909-16. doi: 10.1148/radiol.12111300. Epub 2012 Mar 21.
PubMed 22438360Lim HK, Lee JH, Ha EJ, Sung JY, Kim JK, Baek JH. Radiofrequency ablation of benign non-functioning thyroid nodules: 4-year follow-up results for 111 patients. Eur Radiol. 2013 Apr;23(4):1044-9. doi: 10.1007/s00330-012-2671-3. Epub 2012 Oct 25.
PubMed 23096937
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microwave Ablation Versus Radiofrequency Ablation for the Treatment of Moderate-sized Benign Thyroid Nodules, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06426563
- Acronym / sponsor ID
- UW 24-141
- Conditions
- Thyroid Nodule \(Benign\), Ablation Therapy
- Keywords
- Ablation therapy, Thyroid nodule, benign, RFA, MWA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thyroid nodule is a common condition that affects up to 60% of the population. There is an estimated 10% lifetime probability of developing a thyroid nodule. Although most thyroid nodules are benign, up to 10-15% can enlarge to cause compressive symptoms including neck pressure and discomfort, dysphagia, dyspnea, and dysphonia. The conventional treatment for these benign but problematic nodules has been thyroidectomy. Although generally a low risk operation, thyroidectomy is associated with some risk for recurrent laryngeal nerve injury, bleeding, infection, and need for thyroid hormone supplementation. Since the early 2000s, ultrasound-guided percutaneous thermal ablation has emerged as a potential alternative treatment to surgery for benign thyroid nodules. Of the myriad ablation methods, the most commonly used techniques are radiofrequency ablation (RFA) and microwave ablation (MWA). [1-3] A growing body of evidence shows that RFA is an effective treatment for benign solid thyroid nodules, toxic adenomas, and thyroid cysts resulting in overall volume reduction ranges of 40-80% at 1 year, with durable resolution of compressive and hyperthyroid symptoms. However, RFA is not without its limitations. Radiofrequency waves can be limited by the heat sink effect and tissue char leading to longer procedure times and potentially less optimal outcomes in larger, hypervascular, and/or more cystic nodules.
Microwave ablation (MWA) is another ablative technique that uses electromagnetic energy waves to cause tissue hyperthermia and coagulative necrosis. It generally causes higher ablation temperatures than RFA and is less subject to the heat sink effect, and therefore can facilitate more efficient ablation procedures. Current evidence comparing RFA versus MWA for thyroid ablation was limited and was either retrospective, non-randomized [4-9], under-powered, or with an unequal baseline. The results from these studies were also conflicting, suggesting suboptimal quality of evidence and bias due to non-standardized technique of ablation across studies. To date, there is no randomized controlled trial comparing the efficacy and safety of RFA versus MWA for the treatment of benign thyroid nodules. Given the higher ablation temperatures, freedom from heat sink effect, and no influence from impedance changes during ablation, MWA may achieve different treatment efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group is for radiofrequency ablation treatment (RFA), another group is for microwave ablation treatment (MWA)
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation treatment (RFA) to thyroid nodule | Active comparator | Procedure: Ablation treatment of thyroid noduleParticipants who are undergo thyroid nodule treatment by RFA |
| Microwave ablation treatment (MWA) to thyroid nodule | Active comparator | Procedure: Ablation treatment of thyroid noduleParticipants who are undergo thyroid nodule treatment by MWA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients \>/=18 years of age
- Nodule maximal diameter ≥2cm and nodule volume \<20ml
- Nodule being predominantly solid (≥80% solid)
- Confirmed benign nature of nodules, either by : two benign fine needle biopsies, with the most recent biopsy performed within 1 year of enrollment in study or one benign fine needle biopsy and low suspicion characteristics on ultrasound
- Both functional and non-functional nodules are eligible.
Key exclusion criteria (3 listed)
- Cytologically indeterminate nodules
- Nodules with substernal extension or posterior extension that cannot be viewed sufficiently with ultrasound
- current pregnancy or cardiac arrhythmias; presence of pacemaker or any medical condition that renders patient unfit for thermal ablation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation treatment of thyroid noduleUse Radiofrequency or Microwave ablation device to treat thyroid nodule | Procedure or surgery | Microwave ablation treatment (MWA) to thyroid nodule, Radiofrequency ablation treatment (RFA) to thyroid nodule |
Primary outcome
To measure the volume reduction ratio (VRR) of the first ablated nodule at each procedure at 12-months post-procedure
Time frame: 12 months
7 secondary outcomes
To measures nodule recurrence rate
Time frame: 12-24 months
To measures thyroid nodule regrowth rate
Time frame: 12-24 months
To measure cosmetic score by investigator (1-4)
Time frame: 12-24 months
To measure the compressive symptom scores (from 0 - 100)
Time frame: 12-24 months
To measure swallowing impairment scores by questionnaire (SIS-6)
Time frame: 12-24 months
To measure pain score (0-10) after ablation treatment
Time frame: 12-24 months
Change of quality of life by SF12 ver 2
Time frame: 12-24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 35313358Lang BHH, Fung MMH. Safety and Efficacy of Single-Session Radiofrequency Ablation Treatment for Benign Non-toxic Multinodular Goiter. World J Surg. 2022 Jul;46(7):1704-1710. doi: 10.1007/s00268-022-06527-8. Epub 2022 Mar 21.
- Background: PubMed 28842651Cheng Z, Che Y, Yu S, Wang S, Teng D, Xu H, Li J, Sun D, Han Z, Liang P. US-Guided Percutaneous Radiofrequency versus Microwave Ablation for Benign Thyroid Nodules: A Prospective Multicenter Study. Sci Rep. 2017 Aug 25;7(1):9554. doi: 10.1038/s41598-017-09930-7.
- Background: PubMed 29333159Wu W, Gong X, Zhou Q, Chen X, Chen X. Ultrasound-Guided Percutaneous Microwave Ablation for Solid Benign Thyroid Nodules: Comparison of MWA versus Control Group. Int J Endocrinol. 2017;2017:9724090. doi: 10.1155/2017/9724090. Epub 2017 Nov 23.
- Background: PubMed 33471820He L, Zhao W, Xia Z, Su A, Li Z, Zhu J. Comparative efficacy of different ultrasound-guided ablation for the treatment of benign thyroid nodules: Systematic review and network meta-analysis of randomized controlled trials. PLoS One. 2021 Jan 20;16(1):e0243864. doi: 10.1371/journal.pone.0243864. eCollection 2021.
- Background: PubMed 31939434Hu K, Wu J, Dong Y, Yan Z, Lu Z, Liu L. Comparison between ultrasound-guided percutaneous radiofrequency and microwave ablation in benign thyroid nodules. J Cancer Res Ther. 2019;15(7):1535-1540. doi: 10.4103/jcrt.JCRT_322_19.
- Background: PubMed 33556187Guo DM, Chen Z, Zhai YX, Su HH. Comparison of radiofrequency ablation and microwave ablation for benign thyroid nodules: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2021 Jul;95(1):187-196. doi: 10.1111/cen.14438. Epub 2021 Mar 2.
- Background: PubMed 33767666Jin H, Fan J, Lu L, Cui M. A Propensity Score Matching Study Between Microwave Ablation and Radiofrequency Ablation in Terms of Safety and Efficacy for Benign Thyroid Nodules Treatment. Front Endocrinol (Lausanne). 2021 Mar 9;12:584972. doi: 10.3389/fendo.2021.584972. eCollection 2021.
- Background: PubMed 29962870Kim 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.
- Background: PubMed 22438360Huh JY, Baek JH, Choi H, Kim JK, Lee JH. Symptomatic benign thyroid nodules: efficacy of additional radiofrequency ablation treatment session--prospective randomized study. Radiology. 2012 Jun;263(3):909-16. doi: 10.1148/radiol.12111300. Epub 2012 Mar 21.
- Background: PubMed 23096937Lim HK, Lee JH, Ha EJ, Sung JY, Kim JK, Baek JH. Radiofrequency ablation of benign non-functioning thyroid nodules: 4-year follow-up results for 111 patients. Eur Radiol. 2013 Apr;23(4):1044-9. doi: 10.1007/s00330-012-2671-3. Epub 2012 Oct 25.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation treatment of thyroid nodule in people with Thyroid Nodule \(Benign\) and Ablation Therapy, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Man Him, Matrix Fung, MBBS (+852-22554232, mmhfung@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the volume reduction ratio (VRR) of the first ablated nodule at each procedure at 12-months post-procedure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06426563, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.