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Procedure

Radiofrequency Ablation for Thyroid Cancer

N/A

Waitlist Available

Led By Jonathon Russell, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients between the ages 18-100 with biopsy proven PTMC with a Bethesda V or VI pathology or indeterminate cytology on fine-needle aspiration cytology (FNAC) who are recommended for treatment (Bethesda III/IV)

At least 1 mm of normal tissue as a margin, without sonographic evidence of contact with the capsule

Must not have

Clinically apparent multicentricity

Previous RFA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing the safety, efficacy and oncological outcomes of radiofrequency ablation (RFA) of low risk papillary thyroid microcarcinoma (PTMC) to active surveillance (AS) in patients at Johns Hopkins Medical Institute.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in this summary, potential side effects of RFA may include pain at the site of ablation, swelling or bruising around the neck area where treatment occurs and temporary voice changes due to nerve irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My thyroid cancer has not spread beyond my thyroid.

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I have a single thyroid nodule smaller than 20mm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had radiofrequency ablation before.

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I have voice box nerve damage.

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My thyroid nodule extends to the back of my thyroid.

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My thyroid cancer is not papillary but has specific genetic changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in eating assessment score as assessed by the EAT-10

Change in overall quality of life assessed by the PROMIS score

Change in voice related quality of life as assessed by the VHI-10

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiofrequency AblationExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiofrequency Ablation

2013

Completed Phase 4

~740

0 / 9Eligibility criteria met