Radiofrequency Ablation for Thyroid Nodules

Overseen By Kim Learned, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cardiac arrhythmia, Pregnancy, Neck radiation, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores radiofrequency ablation (RFA) for individuals with benign or low-risk thyroid nodules. RFA uses a needle to deliver electrical energy, heating and destroying the nodule. This method aims to achieve results similar to traditional surgery but with less invasiveness and quicker recovery. It suits those with noticeable thyroid nodules causing discomfort or cosmetic concerns who prefer to avoid or cannot undergo surgery. Participants must have a solid or mostly solid nodule at least 2 cm in size, confirmed as non-aggressive through testing. As an unphased trial, this study provides a unique opportunity for patients to consider a less invasive treatment for thyroid nodules.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for radiofrequency ablation?

Research shows that radiofrequency ablation (RFA) is generally safe for treating thyroid nodules. Past studies have found RFA to be effective and well-tolerated. For instance, one study showed that RFA reduced nodule size by 77% after one year, indicating its long-term effectiveness.

While complications can occur, they are uncommon. Minor issues have been reported in about 4% of cases, and major problems are even rarer, occurring in 1.1% to 1.4% of cases. These low rates suggest that RFA is a safe option for many patients.

Overall, RFA offers a promising treatment for individuals with non-cancerous or low-risk thyroid nodules, providing a less invasive alternative to surgery with a good safety record. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Radiofrequency Ablation (RFA) is unique because it offers a minimally invasive way to shrink thyroid nodules without surgery. Unlike traditional treatments like surgery or watchful waiting, RFA uses heat generated from radio waves to precisely target and destroy nodule tissue, which can reduce the size of nodules while preserving healthy thyroid tissue. Researchers are excited about this technique because it typically results in less recovery time, fewer complications, and avoids the need for lifelong thyroid hormone replacement, which can happen with surgical removal of the thyroid.

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

Research has shown that radiofrequency ablation (RFA) effectively shrinks thyroid nodules. Studies have found that RFA can reduce nodule size by up to 77% within a year. In long-term follow-ups, patients have safely maintained these reductions for over 10 years. Compared to other treatments, RFA often performs better, with patients experiencing a 50% to 80% decrease in nodule size. This evidence suggests that RFA is a promising option for individuals with non-cancerous or low-risk thyroid nodules. ^{2 3 6 7 8}

Who Is on the Research Team?

Kim O. Learned, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with benign thyroid nodules or low-risk thyroid cancer who have symptoms, want treatment but can't or won't have surgery. They must be fit for local anesthesia, able to consent, and the nodule must be visible on ultrasound and confirmed benign or low-risk cancer without metastasis.

Inclusion Criteria

Women who can have babies must have a negative pregnancy test before starting the study.

Your blood tests and thyroid hormone levels are within the normal range, and you don't have specific antibodies related to thyroid issues.

My benign nodule is at least 2 cm, mostly solid, and confirmed benign by tests.

Exclusion Criteria

I am allergic to some anesthesia medications.

You have cysts with less than 70% solid material.

My thyroid cancer has spread beyond the thyroid or to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ultrasound guided radiofrequency ablation (RFA) over 1-2 hours

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in thyroid nodule size and treatment response affecting quality of life

12 months

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

What Are the Treatments Tested in This Trial?

Interventions

• Radiofrequency Ablation

Trial Overview

The study tests radiofrequency ablation (RFA), a less invasive procedure using electric current to heat and destroy tumor cells. It's compared to standard surgery in terms of effectiveness and recovery for treating thyroid nodules or small recurrent cancers.

How Is the Trial Designed?

Group I: Treatment (RFA) Experimental Treatment 2 Interventions

Patients undergo ultrasound guided RFA over 1-2 hours.

Radiofrequency Ablation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Radiofrequency Ablation for:

• Benign thyroid nodules causing compressive symptoms
• Low-risk thyroid nodules

Approved in European Union as Radiofrequency Ablation for:

• Benign thyroid nodules causing compressive symptoms
• Low-risk thyroid nodules

Approved in Canada as Radiofrequency Ablation for:

• Benign thyroid nodules causing compressive symptoms
• Low-risk thyroid nodules

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

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 a safe and effective non-surgical treatment for benign thyroid nodules, with long-term results showing significant volume reduction of nodules.

While RFA has a low risk of major complications (up to 3.8%), careful management of both minor and major complications is essential, and long-term follow-up is necessary to monitor for potential regrowth of nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thyroid Nodule Radiofrequency Ablation: Complications and Clinical Follow Up. Lim, JY., Kuo, JH.[2022]

Ultrasound-guided radiofrequency ablation (RFA) significantly reduced the size of metastatic well-differentiated thyroid carcinoma tumors in 10 patients, with the mean diameter decreasing from 13.8 mm to 3.3 mm after treatment.

RFA was effective in controlling tumor growth in patients who could not undergo surgery, with 83% of tumors treated in a single session and a notable decrease in serum thyroglobulin levels in 7 out of 10 patients, indicating a positive response to the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locoregional control of metastatic well-differentiated thyroid cancer by ultrasound-guided radiofrequency ablation. Baek, JH., Kim, YS., Sung, JY., et al.[2022]

Ultrasound-guided radiofrequency ablation (RFA) effectively reduced the volume of benign thyroid nodules in 1000 patients, achieving over 50% volume reduction in 78.9% of predominantly solid and 78.2% of predominantly cystic lesions after the first treatment, indicating its efficacy across different nodule types.

The only significant factor associated with successful treatment was a smaller nodule volume (less than 4 mL), suggesting that RFA is particularly effective for smaller nodules and can be considered a primary treatment option for benign thyroid nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful radiofrequency ablation strategies for benign thyroid nodules. Lee, GM., You, JY., Kim, HY., et al.[2020]

Ultrasound-guided radiofrequency ablation (RFA) is effective in treating benign thyroid nodules, with significant volume reduction observed over a follow-up period of up to 48 months in a study of 119 patients.

Factors such as lower pre-treatment neck circumference and macrocystic echostructure were identified as positive predictors for achieving a volume reduction rate of 75% or more at 12 months, indicating that selecting appropriate nodules can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictor Analysis in Radiofrequency Ablation of Benign Thyroid Nodules: A Single Center Experience. Bisceglia, A., Rossetto, R., Garberoglio, S., et al.[2022]

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 250 patients undergoing ultrasound-guided radiofrequency ablation (RFA) for benign thyroid nodules, the volume reduction ratio (VRR) improved significantly over 12 months, indicating the treatment's efficacy.

Certain ultrasound characteristics, such as nodules being isoechoic, hyper-vascular, and located in the left lobe, were associated with higher success rates of RFA, suggesting that these factors can help predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of ultrasound parameters of benign thyroid nodules on radiofrequency ablation efficacy. Motaghed, Z., Chegeni, H., Mosadeghkhah, A., et al.[2023]

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]

Ultrasound-guided radiofrequency ablation is a safe and effective non-invasive treatment for benign thyroid nodules that are at least 2 cm in size and less than 20 ml in volume.

The treatment is well-supported by current literature, demonstrating high efficacy, safety, patient satisfaction, and cost-effectiveness, and it also shows promise as an alternative therapy for hyperfunctioning nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ultrasound-guided radiofrequency ablation of benign symptomatic thyroid nodules]. Larsen, KD., Håkansson, K., Papesch, M., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8187951/

Long-Term Results of Ultrasound-Guided Radiofrequency ...

A recent review by Sim (24) have summarized the data and have shown that for 54 patients who underwent RFA treatment, the mean FU period was 39.4 ± 21.7 months, ...

2.

cambridgeinterventional.com

cambridgeinterventional.com/10-year-clinical-follow-up-for-rfa-of-thyroid-nodules/

10-Year Clinical Follow-up for RFA of Thyroid Nodules

RFA can produce safe, substantial, and durable nodule volume reduction over 10 years. Regular follow-up is suggested due to possible nodular ...

3.

academic.oup.com

academic.oup.com/jcem/article/110/11/3201/7989440

Radiofrequency Ablation for Thyroid Nodules (RATED Study)

Long-term follow-up of RFA has shown that the treatment is safe and successful, reducing nodule volume by 77% 1 year after treatment (3). In ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39046500/

Comparative efficacy and safety of radiofrequency ablation ...

RFA showed a higher VRR at 12 months than MWA. Both techniques are effective for treating thyroid nodules; RFA offers greater benefits, ...

5.

mayoclinic.org

mayoclinic.org/medical-professionals/endocrinology/news/radiofrequency-ablation-therapy-for-large-benign-thyroid-nodules/mac-20439239

Radiofrequency ablation therapy for large benign thyroid ...

Clinical trials in Italy and South Korea demonstrated a 50 to 80 percent durable nodule shrinkage after thyroid nodule RFA. Marius N. Stan, M.D., with ...

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.

facs.org

facs.org/for-medical-professionals/news-publications/news-and-articles/acs-brief/april-8-2025-issue/rfa-is-safe-effective-for-molecular-negative-bethesda-iii-thyroid-nodules/

RFA Is Safe, Effective for Molecular Negative Bethesda III ...

The authors concluded that RFA was safe for patients with Bethesda III thyroid nodules with low-risk molecular profiles, but longer follow up data are needed.

8.

pubs.rsna.org

pubs.rsna.org/doi/full/10.1148/rg.220021

Radiofrequency Ablation of Benign and Malignant Thyroid ...

The rate of minor complications is reported to be approximately 4%, with a 1.1%–1.4% rate of major complications (27,38). Table 3: Reported ...