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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Traditionally, surgery has been the standard recommendation for treating papillary thyroid cancer. The risk of surgery including permanent hoarseness, permanent hypocalcemia, a mid-cervical scar, and the potential for permanent hypothyroidism may be unacceptable for some patients, especially with low risk papillary thyroid carcinoma. The recent American Thyroid Association guidelines have proposed the option of active surveillance with low risk papillary thyroid cancer less than 210 mm. However, most patients find observation anxiety provoking knowing of having cancer. Radiofrequency ablation (RFA) of small low risk papillary thyroid cancer is a promising therapeutic modality for these patients that reduces the risks associated with surgery and the anxiety of taking a watchful approach. However, this technique has not been validated in the North American population. The investigators aim to describe the investigators' initial experience with RFA of low risk papillary thyroid microcarcinoma (PTMC) compared to active surveillance (AS) done by Head and Neck Endocrine surgeons at Johns Hopkins Medical Institute. Primary objective: * To evaluate the safety, efficacy and oncological outcomes of the procedure. Secondary objective: * To determine the patient functional outcomes in comparison to the observational control.

Research Team

Jonathon Russell, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+