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Procedure

RFA for Thyroid Cancer

Q: Is enrollment for this research study currently open?

<p>According to the clinicaltrials.gov, this medical research is no longer recruiting participants. The study was initially advertised on June 15th 2020 and saw its last update on July 21st 2022. However, there are 228 other trials that are taking in patients at present time.</p>

N/A

Waitlist Available

Led By Marius Stan, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Adults

Radiology evaluation deems the lesion amenable to RFA therapy with minimal risk of complication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study Summary

This trial will test how well Radiofrequency ablation (RFA) therapy works to treat papillary thyroid carcinoma.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the description doesn't specify side effects of RFA directly, common ones may include pain at the treatment site, swelling or bruising around the neck area where the procedure was done and potential damage to nearby structures in rare cases.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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

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My doctor agrees non-surgical treatment is right for me.

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My thyroid nodule is identified as papillary carcinoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in thyroid nodule size (overall volume measured in percentage)

Secondary outcome measures

Development of distant metastasis

Development of lymph node involvement

Pain related to RFA procedure

+1 more

Side effects data

From 2017 Phase 1 & 2 trial • 61 Patients • NCT01853618

100%

Anemia

100%

Aspartate aminotransferase increased

100%

Hyponatremia

88%

Alanine aminotransferase increased

88%

Hypoalbuminemia

88%

Alkaline phosphatase increased

88%

Lymphocyte count decreased

75%

Blood bilirubin increased

63%

Platelet count decreased

63%

Rash maculo-papular

63%

Hypercalcemia

63%

Pain

50%

Activated partial thromboplastin time prolonged

50%

White blood cell decreased

50%

Pruritus

38%

Back pain

38%

Nausea

38%

Constipation

38%

Creatinine increased

38%

Fatigue

38%

Hypophosphatemia

38%

Fever

38%

Vomiting

25%

Headache

25%

Anorexia

25%

Dyspnea

25%

Generalized muscle weakness

25%

Insomnia

25%

Hyperglycemia

25%

Hypermagnesemia

25%

Hypokalemia

25%

Hyperuricemia

25%

Pleural effusion

25%

Cough

25%

Hypomagnesemia

25%

Skin hyperpigmentation

13%

Hyperkalemia

13%

Peripheral sensory neuropathy

13%

Hypertension

13%

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, HCC

13%

Non-cardiac chest pain

13%

Muscle weakness left-sided

13%

Bile duct stenosis

13%

Bloating

13%

Dizziness

13%

Dysphagia

13%

Hearing impaired

13%

Hematuria

13%

Hyperhidrosis

13%

Muscle weakness upper limb

13%

Rash acneiform

13%

Sinus tachycardia

13%

Lymphocyte count increased

13%

Neutrophil count decreased

13%

Urinary tract infection

13%

Diarrhea

13%

CPK increased

13%

Gastrointestinal disorders - Other, Gastroenteritis

13%

Lung infection

13%

Dyspepsia

13%

Ascites

13%

Skin and subcutaneous tissue disorders - Other, mouth ulcers

13%

Edema limbs

13%

Seizure

13%

Eyelid function disorder

13%

Pain in extremity

13%

Productive cough

13%

Weight loss

13%

Neuralgia

13%

Urinary frequency

13%

Bone pain

13%

Paresthesia

13%

Renal and urinary disorders - Other, Dysuria

13%

Serum amylase increased

13%

Pneumothorax

13%

Abdominal distension

13%

Abdominal pain

100%

80%

60%

40%

20%

Study treatment Arm

Pilot 1/Arm A1-Tremelimumab + RFA or TACE

2/Arm A2 -Tremelimumab + RFA or TACE

3/Arm B - Tremelimumab + TACE

5/Arm D - Tremelimumab + Cryoablation

6/Arm E - Tremelimumab + RFA

Trial Design

1Treatment groups

Experimental Treatment

Group I: RFA GroupExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RFA

2014

Completed Phase 2

~1650

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,779 Total Patients Enrolled

Marius Stan, MDPrincipal Investigator - Mayo Clinic

Mayo Clinic Hospital-Rochester Saint Marys Campus, Mayo Clinic Rochester

University De Medical Si Farm Iuliu Hatieganu (Medical School)

Mayo Grad School Med/Mayo Fndn (Residency)

2 Previous Clinical Trials

66 Total Patients Enrolled

Media Library

RFA (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04129411 — N/A

Thyroid Cancer Research Study Groups: RFA Group

Thyroid Cancer Clinical Trial 2023: RFA Highlights & Side Effects. Trial Name: NCT04129411 — N/A

RFA (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04129411 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age requirement for this trial over 45 years old?

"Compliant with the enrollment parameters for this investigation, applicants must be at least 18 years old but not older than 85."

Answered by AI

Are there any eligibility criteria that would preclude me from participating in this trial?

"The research team is searching for 5 participants with a diagnosis of papillary thyroid cancer, aged 18-85. The size of the tumour must be <1.5 cm, and non-surgical management should be approved by their medical practitioner."

Answered by AI

Is enrollment for this research study currently open?

"According to the clinicaltrials.gov, this medical research is no longer recruiting participants. The study was initially advertised on June 15th 2020 and saw its last update on July 21st 2022. However, there are 228 other trials that are taking in patients at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

Marius Stan 2020. "Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04129411.

All > Thyroid Cancer > Thyroid