Radiofrequency Ablation for Thyroid Nodules

Overseen by Daniel Kuriloff, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwell Health

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Pregnancy, Pacemaker, Malignant nodule, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is studying a procedure called radiofrequency ablation (RFA) for Latinx patients with non-cancerous thyroid nodules that cause symptoms. RFA uses heat from radio waves to shrink or destroy the nodules without surgery. The goal is to see if RFA is a safe and effective alternative to surgery for these patients. RFA is a minimally invasive technique that has been widely used for the management of benign thyroid nodules, with evidence supporting its safety and efficacy.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulation (blood thinners) or dual antiplatelet therapy (medications that prevent blood clots).

What data supports the effectiveness of the treatment Mygen V-1000 RF system for thyroid nodules?

Research shows that radiofrequency ablation (RFA) can significantly reduce the size of benign thyroid nodules, with volume reductions of 33-58% after one month and 51-85% after six months. This treatment also improves symptoms related to the nodules, making it an effective option for managing benign thyroid conditions. ^{1 2 3 4 5}

Is radiofrequency ablation safe for treating thyroid nodules?

Radiofrequency ablation (RFA) for benign thyroid nodules is generally safe, with some patients experiencing minor complications like pain, hematoma (a bruise or collection of blood outside of blood vessels), and temporary voice changes. Studies show that these side effects are usually not severe and do not require hospitalization. ^{6 7 8 9 10}

How is the Mygen V-1000 RF system treatment for thyroid nodules different from other treatments?

The Mygen V-1000 RF system uses radiofrequency ablation (RFA), a minimally invasive technique that reduces the size of benign thyroid nodules by applying heat to destroy tissue, offering an alternative to surgery with a good safety profile and significant volume reduction over time. ^{1 3 4 11 12}

Research Team

Daniel Kuriloff, MD

Principal Investigator

Northwell Health

Eligibility Criteria

This trial is for Latinx individuals over 18 with benign, symptomatic thyroid nodules who can consent to treatment and follow study procedures. They must have a well-defined nodule on ultrasound. It's not for those on blood thinners, with acute illness, high blood pressure, cardiac devices, or pregnant/breastfeeding women.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study

I am over 18 years old.

My thyroid nodule is clearly outlined and surrounded by normal tissue.

Exclusion Criteria

I am unable to give consent for medical procedures.

My tumor is mostly solid and confirmed malignant.

You are currently sick with a serious health problem.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo radiofrequency ablation for symptomatic benign thyroid nodules

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

5 visits (in-person) at 1, 3, 6, 12, and 18 months

Treatment Details

Interventions

• Mygen V-1000 RF system (Procedure)

Trial Overview The Mygen V-1000 RF system is being tested as a minimally-invasive alternative to surgery for treating thyroid nodules in Latinx patients. The goal is to see if radiofrequency ablation (RFA) can safely resolve issues without the risks associated with traditional surgery.

Participant Groups

Group I: Mygen V-1000 RF system Experimental Treatment 1 Intervention

The Mygen V-1000, a microprocessor-based generator of RF Medical Co., Ltd., provides up to 140 watts of radio-frequency (RF) energy to be used for coagulation \& ablation of vessel, tissue \& bone

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Michael Dowling

Northwell Health

Chief Executive Officer since 2002

Bachelor's and Master's degrees from University College Cork, Ireland

Dr. David Battinelli

Northwell Health

Chief Medical Officer since 2022

MD from Georgetown University School of Medicine

Findings from Research

Radiofrequency ablation (RFA) significantly reduced the volume of benign thyroid nodules, with the most substantial reductions seen in smaller nodules, decreasing from an average of 24.5 mL to 8.6 mL after 6 months.

RFA improved cosmetic outcomes for all treated patients and alleviated pressure symptoms in medium and large nodules, while untreated nodules showed no volume change and worsened symptoms over the same period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study of effectiveness of ultrasound-guided radiofrequency ablation versus control group in patients affected by benign thyroid nodules. Cesareo, R., Pasqualini, V., Simeoni, C., et al.[2015]

In a study of 43 patients, radiofrequency (RF) ablation treatment led to an impressive average volume reduction of 69.1% in benign thyroid nodules, regardless of whether they were functioning or non-functioning.

The treatment was found to be safe, with no major complications reported, and effectively restored normal thyroid function in patients with autonomously functioning nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency ablation of functioning and non-functioning thyroid nodules: a single institution 12-month survey. Cappelli, C., Franco, F., Pirola, I., et al.[2022]

A machine learning model was developed using data from 402 benign thyroid nodules treated with radiofrequency (RF) to predict which nodules would have a volume reduction rate (VRR) of 50% or more after 12 months, achieving an accuracy of 85%.

The model's ability to distinguish between good and poor responders to RF treatment can assist physicians in making informed decisions about whether to pursue thermal ablation or surgery, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Machine Learning Prediction of Radiofrequency Thermal Ablation Efficacy: A New Option to Optimize Thyroid Nodule Selection. Negro, R., Rucco, M., Creanza, A., et al.[2022]

Radiofrequency (RF) ablation is an effective minimally invasive treatment for benign thyroid nodules, achieving volume reductions of 33-58% after one month and 51-85% after six months.

RF ablation not only reduces the size of benign nodules but also improves symptoms and shows promising short-term results for controlling locoregional recurrence in patients with thyroid cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency ablation of thyroid nodules: basic principles and clinical application. Shin, JH., Baek, JH., Ha, EJ., et al.[2021]

The study of 90 radiofrequency ablation (RFA) procedures for benign thyroid nodules showed a learning curve in operator experience, with significant improvements in technique efficacy (TE) and volume reduction ratio (VRR) observed between the first 30 procedures and the next 30, indicating that operator experience positively impacts treatment outcomes.

The procedure was found to be safe, with only three minor complications reported, all of which resolved with conservative treatment, confirming that RFA for benign thyroid nodules is a low-risk intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning curve for radiofrequency ablation of benign thyroid nodules. Russ, G., Ben Hamou, A., Poirée, S., et al.[2021]

In a study of 60 patients, radiofrequency ablation (RFA) resulted in a significantly greater reduction in thyroid nodule volume (64.3%) compared to laser ablation (LA) (53.2%) after six months, indicating RFA may be more effective for treating benign thyroid nodules.

Both RFA and LA had similar success rates in reducing symptoms and cosmetic concerns, and the safety profiles were comparable, with no serious complications requiring hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser Ablation Versus Radiofrequency Ablation for Benign Non-Functioning Thyroid Nodules: Six-Month Results of a Randomized, Parallel, Open-Label, Trial (LARA Trial). Cesareo, R., Pacella, CM., Pasqualini, V., et al.[2021]

Radiofrequency ablation (RFA) is a safe and effective treatment for large benign solid thyroid nodules, achieving significant volume reduction of up to 99.4% after a single session and 98.4% after sequential treatments, based on a study of 24 patients over a median follow-up of 23.5 months.

The procedure resulted in only slight temporary increases in thyroid hormone levels (FT3 and FT4) immediately after RFA, which normalized within a month, indicating minimal impact on thyroid function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significance of radiofrequency ablation in large solid benign thyroid nodules. Lin, Y., Shi, YP., Tang, XY., et al.[2022]

In a study of 35 patients undergoing radiofrequency ablation (RFA) for benign thyroid nodules, the technique showed a mean efficacy of 55.6% at 1 month and 24.1% at 6 months, indicating a significant reduction in nodule size over time.

While the incidence of bleeding complications was low, there were cases of intranodular hematoma and voice changes, highlighting the importance of understanding potential risks and having proper management strategies in place.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of bleeding associated with radiofrequency ablation of benign thyroid nodules. Hu, K., Lian, Y., Wang, J., et al.[2021]

In a study involving 21 patients with symptomatic benign thyroid nodules, the novel radiofrequency ablation (RFA) technique using an adjustable electrode achieved a significant mean volume reduction of 68.3% at follow-up, with a therapeutic success rate of 90.5%.

The procedure was found to be safe, with only minor complications reported in three patients, indicating that this RFA method is both effective and has a favorable safety profile for treating thyroid nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Adjustable Electrodes for Radiofrequency Ablation of Benign Thyroid Nodules. Lee, J., Shin, JH., Hahn, SY., et al.[2020]

Radiofrequency ablation (RFA) is an effective treatment for benign thyroid nodules, achieving an average volume reduction of 74.51% within one year based on a study of 116 patients with 137 nodules.

Pre-ablation ultrasound characteristics, particularly cyst composition, can help predict treatment success, and post-ablation ultrasound changes may lead to misinterpretation of nodules as potentially malignant, highlighting the need for careful follow-up imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in the ultrasonographic appearance of thyroid nodules after radiofrequency ablation. Wu, MH., Chen, KY., Chen, A., et al.[2021]

Radiofrequency ablation (RFA) is safe and effective for treating bilateral thyroid nodules, achieving a mean volume reduction rate of 64% after 6 months in a single-setting treatment of 6 patients.

The safety profile of RFA remains strong, with no reported complications in both the single-setting cohort and a control group treated in a separate setting, suggesting its viability for managing multiple nodules simultaneously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral nodule radiofrequency ablation in a single setting: First reported case series. Issa, PP., Magazine, BM., LaForteza, A., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prospective study of effectiveness of ultrasound-guided radiofrequency ablation versus control group in patients affected by benign thyroid nodules. [2015]

2. Italy pubmed.ncbi.nlm.nih.gov

Radiofrequency ablation of functioning and non-functioning thyroid nodules: a single institution 12-month survey. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Machine Learning Prediction of Radiofrequency Thermal Ablation Efficacy: A New Option to Optimize Thyroid Nodule Selection. [2022]

4. Egypt pubmed.ncbi.nlm.nih.gov

Radiofrequency ablation of thyroid nodules: basic principles and clinical application. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Learning curve for radiofrequency ablation of benign thyroid nodules. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Radiofrequency ablation of benign thyroid nodules: safety and imaging follow-up in 236 patients. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Laser Ablation Versus Radiofrequency Ablation for Benign Non-Functioning Thyroid Nodules: Six-Month Results of a Randomized, Parallel, Open-Label, Trial (LARA Trial). [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Significance of radiofrequency ablation in large solid benign thyroid nodules. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Management of bleeding associated with radiofrequency ablation of benign thyroid nodules. [2021]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Feasibility of Adjustable Electrodes for Radiofrequency Ablation of Benign Thyroid Nodules. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Differences in the ultrasonographic appearance of thyroid nodules after radiofrequency ablation. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Bilateral nodule radiofrequency ablation in a single setting: First reported case series. [2023]