Radiofrequency Ablation for Thyroid Nodules

Overseen By Jose Sanchez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Pregnancy, Pacemaker, Malignant nodule, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 day

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating thyroid nodules using radiofrequency ablation. Thyroid nodules can cause discomfort, cosmetic issues, or hormone imbalance. The study aims to determine if a minimally-invasive procedure can help, specifically for Latinx patients. The trial employs the Mygen V-1000 RF system, which uses radio waves to shrink or destroy tissue without surgery. Latinx individuals with benign thyroid nodules causing symptoms and having a specific ultrasound appearance may be suitable candidates. This approach provides an alternative for those wishing to avoid surgical risks. As an unphased trial, it offers an opportunity to explore innovative treatment options that could improve quality of life without surgery.

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 prior data suggests that radiofrequency ablation is safe for treating thyroid nodules?

Research has shown that radiofrequency ablation (RFA) safely treats non-cancerous thyroid nodules, especially smaller ones. The Mygen V-1000 RF system, used in this treatment, ensures accuracy and safety. Patients generally tolerate the procedure well, and it serves as an alternative to surgery. This method avoids surgical risks and can be performed outside a traditional operating room. Studies have not reported any major side effects, indicating that RFA is a safe and effective option for those seeking to avoid surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike other treatments for thyroid nodules, which often involve surgery or radioactive iodine therapy, the Mygen V-1000 RF system uses radiofrequency ablation to target and shrink nodules. This system is unique because it provides up to 140 watts of RF energy, allowing for precise coagulation and ablation of tissue. This minimally invasive approach can lead to quicker recovery times and fewer complications compared to traditional surgical methods. Researchers are excited about this treatment because it offers a less invasive option with the potential for effective results and improved patient comfort.

What evidence suggests that radiofrequency ablation is effective for benign thyroid nodules?

Research has shown that radiofrequency ablation (RFA) effectively treats non-cancerous thyroid nodules. In one study with 43 patients, RFA treatment reduced nodule size by an average of 69.1%, significantly shrinking them. The Mygen V-1000 RF system, used in this trial, demonstrated precision and safety. This minimally invasive technique involves less cutting than surgery, reducing surgical risks while providing significant relief from symptoms caused by thyroid nodules. ^{1 3 5 6 7}

Who Is on the Research Team?

Daniel Kuriloff, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Mygen V-1000 RF system

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.

How Is the Trial Designed?

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

Mygen V-1000 RF system is already approved in United States, European Union for the following indications:

Approved in United States as Radiofrequency Ablation for:

• Benign symptomatic thyroid nodules

Approved in European Union as Radiofrequency Ablation for:

• Benign symptomatic thyroid nodules
• Autonomously functioning thyroid nodules

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Published Research Related to This Trial

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 (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]

Radiofrequency ablation (RFA) is a safe and effective treatment for benign thyroid nodules, achieving an average volume reduction ratio of 84.11% in a study of 302 nodules from 236 patients.

The procedure resulted in significant volume reduction, with 91.06% of nodules showing more than 50% reduction and 27.81% completely disappearing, while complications were generally mild, including pain and transient voice changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency ablation of benign thyroid nodules: safety and imaging follow-up in 236 patients. Jeong, WK., Baek, JH., Rhim, H., et al.[2022]

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]

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]

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]

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]

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 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]

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]

Citations

1. rgshealthcare.com rgshealthcare.com/thyroid-ablation/radiofrequency-rf-ablation-system-v-1000/

RADIOFREQUENCY RF ABLATION SYSTEM V-1000 for ... Discover the RADIOFREQUENCY RF ABLATION SYSTEM V-1000—an advanced thyroid treatment platform offering precision, safety, and physician-trusted results.

2. withpower.com withpower.com/trial/phase-thyroid-nodule-7-2023-1cb00

Radiofrequency Ablation for Thyroid Nodules 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 ...

3. wjoes.com wjoes.com/abstractArticleContentBrowse/WJOES/24487/JPJ/fullText

Factors Associated with the Efficacy of Radiofrequency ... Some factors related to the efficacy of RFA in the treatment of thyroid nodules have been reported, including initial volume, US structure, and vascularity of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11333423/

Adjustable-tip needles versus fixed ... In this retrospective, observational study we aim to compare the outcomes of the RFA treatment of benign thyroid nodules, ...

5. rgshealthcare.com rgshealthcare.com/future-of-thyroid-nodule-therapy-with-the-rfa-v-1000/

The Future of Thyroid Nodule Therapy With The RFA V-1000 Efficacy and Safety ... Radio Frequency Ablation (RFA) with the RFA V-1000 by RGS Healthcare shows promise in treating thyroid nodules effectively and safely.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8271212/

Safety and Efficacy of Radiofrequency Ablation of Thyroid ... RFA is a safe and efficacious treatment for symptomatic NFTNs and AFTNs in our population and is especially effective for smaller nodules.

7. researchgate.net researchgate.net/publication/353816898_Efficacy_and_Safety_of_Single-Session_Radiofrequency_Ablation_in_Treating_Benign_Thyroid_Nodules_A_Short-Term_Prospective_Cohort_Study

(PDF) Efficacy and Safety of Single-Session ... Conclusion: RFA was demonstrated as a safe and effective option for benign thyroid nodules treatment. It can be used as an alternative treatment with ...