RFA for Thyroid Cancer

Overseen By Vishakantha Murthy, PhD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Anticoagulants, Investigational drugs

Disqualifiers: Multifocal malignancy, Metastatic disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of Radiofrequency ablation (RFA) therapy for treating papillary thyroid carcinoma, a type of thyroid cancer. RFA uses heat to destroy cancer cells, and the trial aims to determine its effectiveness and safety for small thyroid tumors (less than 1.5 cm). It is suitable for adults diagnosed with papillary thyroid carcinoma through a needle test, whose tumors can be treated without surgery. Individuals with cancer spread, multiple tumors, or certain health issues should not join this trial. As an unphased study, this trial provides a unique opportunity to explore innovative treatment options 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 if you are on anticoagulation therapy (blood thinners), you cannot participate. Also, if you are part of another drug trial, you need to stop that treatment at least 6 weeks before this trial.

What prior data suggests that RFA is safe for treating papillary thyroid carcinoma?

Research has shown that Radiofrequency Ablation (RFA) safely treats small thyroid cancers. This minimally invasive treatment carries a low risk of side effects. In one study, all treated tumors disappeared after 24 months, indicating excellent results. Another study found significant tumor shrinkage, with few reports of serious side effects. These findings suggest that RFA is generally well-tolerated and offers a promising option for treating papillary thyroid carcinoma. ^{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 compared to traditional surgical methods. While most standard treatments involve surgery or radioactive iodine, RFA uses heat generated by radio waves to precisely target and destroy cancerous tissues without the need for a scalpel. This method can result in less scarring, quicker recovery times, and potentially fewer complications. Researchers are excited about RFA because it provides a promising alternative for patients who may not be ideal candidates for surgery or who prefer a less invasive treatment option.

What evidence suggests that RFA 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. One study found that 94.3% of tumors disappeared completely. Another study demonstrated that after 10 years, RFA achieved a 91.9% rate of complete tumor disappearance in recurrent cases. Additionally, the overall rate of tumor growth remained low, at just 1.5% over approximately 33 months. These findings suggest that RFA can significantly shrink tumors and maintain its effectiveness over time. ^{2 3 6 7 8}

Who Is on the Research Team?

Marius Stan, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with a small papillary thyroid carcinoma (less than 1.5 cm) that can be treated without surgery, as decided by their doctor and radiologist. It's not for those with widespread cancer, pregnant women, individuals who have difficult neck anatomy for RFA access, high anesthesia risk due to other illnesses, recent investigational drug use, substance abuse issues, blood clotting disorders or prior neck treatments.

Inclusion Criteria

I am 18 years old or older.

Diagnosed using fine needle aspiration (FNA) testing.

My scans show I can have RFA therapy with low risk.

Exclusion Criteria

My opposite side vocal cord is paralyzed.

Pregnancy

My cancer has spread 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 radiofrequency ablation (RFA) therapy for papillary thyroid carcinoma

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in primary tumor volume, lymph node involvement, distant metastasis, and serum thyroid hormone levels

18 months

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• RFA

Trial Overview The study is testing Radiofrequency Ablation (RFA), which uses heat to destroy cancer cells in treating papillary thyroid carcinoma. The goal is to see how effective RFA is at eliminating the tumor while minimizing risks.

How Is the Trial Designed?

Group I: RFA Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

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

Ten-Year Outcomes of Radiofrequency Ablation for Locally ... Among the 24 patients with 37 recurrent PTCs followed up for over 10 years, the VRR was 99.9% and the complete tumor disappearance rate was 91.9%. This ...

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. e-enm.org e-enm.org/journal/view.php?number=2618

Long-Term Outcomes of Radiofrequency Ablation in ... A meta-analysis of 15 such studies demonstrated an overall tumor progression rate of 1.5% with a mean follow-up of 33 months, and lymph node ...

4. 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 ...

5. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2811054

Outcomes and Risk Factors of Radiofrequency Ablation for ... Recent studies have reported favorable clinical outcomes in treating stage T1aN0M0 PTC with RFA, with similar short-term effectiveness as ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39862924/

A game-changing meta-analysis The disappearance rate increased from 61.8 % at 12 months to 91.5 % at 48 months post-RFA. The overall volume reduction rate (VRR) was 99.4 % ...

7. 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 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06929650

Study Details | NCT06929650 | The Safety and Feasibility ... The goal of this clinical trial is to test radiofrequency ablation (RFA) in thyroid cancers ≤2 cm in diameter. The main question it aims to answer is:.