Radiofrequency Ablation for Thyroid Cancer

Overseen By Jonathon Russell, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Other thyroid malignancy, Multicentricity, Pregnancy, 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: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat small, low-risk papillary thyroid cancer without surgery. It uses radiofrequency ablation (RFA), which destroys cancer cells with heat, potentially reducing risks and anxiety compared to traditional surgery or observation. The trial compares the results of RFA with observation to determine which is more effective and safer. It seeks participants with a single thyroid nodule under 2 cm and no signs of cancer spreading. As an unphased trial, it offers a unique opportunity to explore innovative treatment options without surgery.

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 prior data suggests that this technique is safe for treating thyroid cancer?

Research has shown that radiofrequency ablation (RFA) is a promising and safe method for treating small thyroid cancers. Studies have found that RFA can effectively shrink or even eliminate these small tumors over time. For example, one study found that 94.3% of tumors disappeared completely. Another study reported a significant reduction in tumor size, with an average decrease of 99.9%.

Patients generally tolerate RFA well, with many studies noting minimal side effects and a low risk of complications. Research over 10 years indicates that RFA remains safe and effective, with most treated tumors disappearing completely. Overall, the evidence suggests that RFA is a safe treatment for managing small, low-risk thyroid cancers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Radiofrequency Ablation (RFA) is unique because it offers a minimally invasive approach to treating thyroid cancer. Unlike traditional surgery, which can be more invasive and require longer recovery times, RFA uses heat generated by radio waves to precisely target and destroy cancerous tissue. This technique can potentially reduce complications and preserve healthy thyroid tissue. Researchers are excited about RFA because it may provide quicker recovery and fewer side effects, making it an attractive alternative for patients who cannot undergo surgery or prefer a less invasive option.

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

Research has shown that radiofrequency ablation (RFA), the treatment under study in this trial, effectively treats small, early-stage papillary thyroid cancer (PTC). Studies have found that RFA can make tumors disappear in many cases, with one analysis reporting a 94.3% success rate. Another study found that tumors completely disappeared in 91.4% of cases after RFA. Long-term results suggest that RFA is not only effective but also safe, with few complications. This makes RFA a promising option for those seeking alternatives to traditional surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Jonathon Russell, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-100 with a specific small thyroid cancer (PTMC) that hasn't spread and is less than 20mm. It's not for pregnant individuals, those with other types of thyroid cancer, certain genetic mutations, larger tumors, previous RFA treatment, multiple cancers in the thyroid, nerve issues affecting the voice box or evidence of cancer spread.

Inclusion Criteria

I am 18-100 years old with a specific thyroid cancer diagnosis recommended for treatment.

My surgery removed the tumor with a small clear margin and no signs of touching the outer layer.

My thyroid cancer has not spread beyond my thyroid.

Exclusion Criteria

My cancer is present in multiple areas of the same organ.

Tests show that the cancer has spread to lymph nodes in the neck or to other parts of the body.

I have had radiofrequency ablation before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiofrequency ablation (RFA) as a one-time intervention, with a possible second treatment after 6 months if adequate resolution is not noted on ultrasound

6 months

1 visit (in-person) for initial treatment, possible follow-up visit for second treatment

Follow-up

Participants are monitored for safety, efficacy, and oncological outcomes, as well as changes in quality of life, complications, and other functional outcomes

24 months

Regular follow-up visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• Radiofrequency Ablation

Trial Overview The study tests Radiofrequency Ablation (RFA), a less invasive alternative to surgery for treating low-risk papillary thyroid microcarcinoma. The goal is to see if it's safe and effective compared to just watching the tumor without intervention at Johns Hopkins Medical Institute.

How Is the Trial Designed?

Group I: Radiofrequency Ablation Experimental Treatment 1 Intervention

Patients will receive RFA as a one-time intervention, with a possible second treatment after 6 months if adequate resolution is not noted on ultrasound.

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?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

RF Medical Co., Ltd

Collaborator

Trials

1

Recruited

10+

Citations

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

Long-Term Results of Ultrasound-Guided Radiofrequency ... They finally observed a complete disappearance of ablated tumors found in 91.4% (139/152) (60). Conclusion. Thermal ablation is a safe and effective method for ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0167814025000015

Meta-analysis Therapeutic outcomes and safety of ... The pooled results demonstrate that RFA is an effective treatment modality for small, early-stage PTC, with a high cumulative tumor disappearance rate (94.3 %) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11361795/

Ten-Year Outcomes of Radiofrequency Ablation for Locally ... Previous studies have shown promising results for RFA in terms of local tumor control, with a mean VRR of 95.1%–100% and complete disappearance rates of 82.0%– ...

4. thyroid.org thyroid.org/patient-thyroid-information/ct-for-patients/march-2025/vol-18-issue-3-p-11-12/

Long-term data show that RFA remains effective and is low ... This study shows that RFA can be considered a safe approach to the treatment of benign thyroid nodules. Complication rates are low, and RFA is effective in ...

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

Radiofrequency Ablation of Benign and Malignant Thyroid ... Overall, RFA demonstrates a significant reduction in volumes. Certain aspects of technique and nodule morphology may lead to improved outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8199252/

Current Status and Challenges of US-Guided Radiofrequency ... US-guided RFA significantly reduces benign thyroid nodules and destroys most PTMC, and this is generally maintained for at least 5 years after the initial ...

7. 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 ...

8. bulletin.entnet.org bulletin.entnet.org/home/article/22949388/the-current-state-of-radiofrequency-ablation-rfa-in-thyroid-nodules

The Current State of Radiofrequency Ablation (RFA) in ... Several long-term studies have shown the safety and efficacy of RFA in PTMC. Jeong et al. reported a 100% complete disappearance of treated ...