What side effects are associated with this type of intervention?

Common treatments for thyroid cancer include surgery (thyroidectomy), radioactive iodine therapy, and thermal ablation techniques like Radiofrequency Ablation (RFA). Side effects of RFA can include pain, infection, and damage to surrounding tissues. Radioactive iodine therapy may lead to dry mouth, altered taste, and an increased risk of secondary cancers. Surgery can result in complications such as hypocalcemia, vocal cord paralysis, and general surgical risks like infection and bleeding.

What prior FDA approvals exist?

The FDA has approved several treatments for thyroid cancer, including targeted therapies like lenvatinib and sorafenib for advanced differentiated thyroid cancer. While Radiofrequency Ablation (RFA) is a promising technique for treating papillary thyroid carcinoma by thermally ablating tumor cells, it is primarily considered investigational and not yet FDA-approved specifically for thyroid cancer. Other approved treatments focus on systemic therapies rather than localized thermal ablation.

What other types of research exist?

Promising novel alternatives to Radiofrequency Ablation (RFA) for thyroid cancer patients include High-Intensity Focused Ultrasound (HIFU), Microwave Ablation (MWA), and Laser Ablation. These techniques offer minimally invasive options with potential for effective tumor control and reduced side effects. Additionally, advancements in immunotherapy and targeted therapies, such as tyrosine kinase inhibitors, are also emerging as viable options for thyroid cancer treatment.

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Procedure

RFA for Thyroid Cancer

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

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

Be older than 18 years old

Must not have

Vocal cord paralysis on contralateral side

Clinical evidence for local or distant metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the effectiveness of using heat from radio waves to treat small thyroid cancers. It will focus on patients with small papillary thyroid carcinoma and will monitor changes in tumor size and other health indicators after treatment. Radiofrequency ablation (RFA) has been studied as a treatment for small papillary thyroid microcarcinomas, particularly in patients who are ineligible for surgery.

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.

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.

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

Exclusion Criteria

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

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My opposite side vocal cord is paralyzed.

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My cancer has spread to other parts of my body.

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I have been diagnosed with a type of thyroid cancer that has multiple growths.

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I have had surgery or radiation treatment on my neck before.

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My neck shape makes it hard for doctors to perform RFA.

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I have a blood clotting disorder or am on blood thinners.

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

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

Primary study objectives

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

Secondary study objectives

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%

Pain

63%

Platelet count decreased

63%

Rash maculo-papular

63%

Hypercalcemia

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%

Skin hyperpigmentation

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

13%

Peripheral sensory neuropathy

13%

Urinary tract infection

13%

Hyperkalemia

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%

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

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: RFA GroupExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RFA

2014

Completed Phase 2

~1650

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Thyroid cancer treatments primarily aim to remove or destroy cancerous cells. Surgery, such as thyroidectomy, physically removes the tumor and affected thyroid tissue. Radioactive iodine therapy targets thyroid cells with radioactive iodine, which is absorbed by thyroid tissue and destroys cancer cells from within. External beam radiotherapy (EBRT) uses high-energy radiation to kill cancer cells and shrink tumors. Radiofrequency ablation (RFA) involves inserting a needle into the tumor and using high-frequency electrical currents to generate heat, which destroys cancer cells. These treatments are crucial for thyroid cancer patients as they offer different approaches to effectively manage and potentially cure the disease, depending on the cancer's type, stage, and location.