Radiofrequency Ablation for Thyroid Nodules

Overseen by Kim O. Learned, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cardiac arrhythmia, Pregnancy, Neck radiation, others

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase IV trial studies the effect of radiofrequency ablation in treating patients with benign or low risk thyroid nodule. Radiofrequency ablation uses a needle to deliver a high-frequency electric current to kill tumor cells by heating them. The goal of this research study is to learn if ultrasound guided radiofrequency ablation can provide the same treatment result as standard surgical removal of the thyroid nodule, small primary thyroid, or thyroid cancers that have come back. Researchers also want to learn if the procedure can be less invasive and perhaps provide a better recovery response than surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Radiofrequency Ablation for Thyroid Nodules?

Research shows that ultrasound-guided radiofrequency ablation (RFA) is effective and safe for treating benign thyroid nodules, leading to significant size reduction and symptom relief. It is also a promising alternative for nodules that are overactive, providing a non-invasive option with high patient satisfaction. ^{1 2 3 4 5}

Is radiofrequency ablation safe for treating thyroid nodules?

Radiofrequency ablation (RFA) is generally considered a safe treatment for benign thyroid nodules, with major complications occurring in up to 3.8% of cases. It is a non-surgical option that is less invasive than surgery, but long-term follow-up is recommended to monitor for any regrowth of the nodules. ^{1 3 5 6 7}

How is radiofrequency ablation different from other treatments for thyroid nodules?

Radiofrequency ablation (RFA) is a unique treatment for thyroid nodules because it is minimally invasive and uses heat generated by radio waves to reduce the size of the nodules. Unlike surgical options, RFA is performed using ultrasound guidance, which allows for precise targeting of the nodules without the need for large incisions. ^{1 3 7 8 9}

Research Team

Kim O. Learned, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults over 18 with benign thyroid nodules or low-risk thyroid cancer who have symptoms, want treatment but can't or won't have surgery. They must be fit for local anesthesia, able to consent, and the nodule must be visible on ultrasound and confirmed benign or low-risk cancer without metastasis.

Inclusion Criteria

Women who can have babies must have a negative pregnancy test before starting the study.

Your blood tests and thyroid hormone levels are within the normal range, and you don't have specific antibodies related to thyroid issues.

My benign nodule is at least 2 cm, mostly solid, and confirmed benign by tests.

Exclusion Criteria

I am allergic to some anesthesia medications.

You have cysts with less than 70% solid material.

My thyroid cancer has spread beyond the thyroid or to other parts of my body.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ultrasound guided radiofrequency ablation (RFA) over 1-2 hours

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in thyroid nodule size and treatment response affecting quality of life

12 months

4 visits (in-person) at 1, 3, 6, and 12 months

Treatment Details

Interventions

• Radiofrequency Ablation (Procedure)

Trial Overview The study tests radiofrequency ablation (RFA), a less invasive procedure using electric current to heat and destroy tumor cells. It's compared to standard surgery in terms of effectiveness and recovery for treating thyroid nodules or small recurrent cancers.

Participant Groups

Group I: Treatment (RFA) Experimental Treatment 2 Interventions

Patients undergo ultrasound guided RFA over 1-2 hours.

Radiofrequency Ablation is already approved in Canada for the following indications:

Approved in Canada as Radiofrequency Ablation for:

• Benign thyroid nodules causing compressive symptoms
• Low-risk thyroid nodules

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Findings from Research

Ultrasound-guided radiofrequency ablation (RFA) effectively reduced the volume of benign thyroid nodules in 1000 patients, achieving over 50% volume reduction in 78.9% of predominantly solid and 78.2% of predominantly cystic lesions after the first treatment, indicating its efficacy across different nodule types.

The only significant factor associated with successful treatment was a smaller nodule volume (less than 4 mL), suggesting that RFA is particularly effective for smaller nodules and can be considered a primary treatment option for benign thyroid nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful radiofrequency ablation strategies for benign thyroid nodules. Lee, GM., You, JY., Kim, HY., et al.[2020]

In a study of 250 patients undergoing ultrasound-guided radiofrequency ablation (RFA) for benign thyroid nodules, the volume reduction ratio (VRR) improved significantly over 12 months, indicating the treatment's efficacy.

Certain ultrasound characteristics, such as nodules being isoechoic, hyper-vascular, and located in the left lobe, were associated with higher success rates of RFA, suggesting that these factors can help predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of ultrasound parameters of benign thyroid nodules on radiofrequency ablation efficacy. Motaghed, Z., Chegeni, H., Mosadeghkhah, A., et al.[2023]

Ultrasound-guided radiofrequency ablation (RFA) is effective in treating benign thyroid nodules, with significant volume reduction observed over a follow-up period of up to 48 months in a study of 119 patients.

Factors such as lower pre-treatment neck circumference and macrocystic echostructure were identified as positive predictors for achieving a volume reduction rate of 75% or more at 12 months, indicating that selecting appropriate nodules can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictor Analysis in Radiofrequency Ablation of Benign Thyroid Nodules: A Single Center Experience. Bisceglia, A., Rossetto, R., Garberoglio, S., et al.[2022]

Ultrasound-guided radiofrequency ablation (RFA) significantly reduced the size of metastatic well-differentiated thyroid carcinoma tumors in 10 patients, with the mean diameter decreasing from 13.8 mm to 3.3 mm after treatment.

RFA was effective in controlling tumor growth in patients who could not undergo surgery, with 83% of tumors treated in a single session and a notable decrease in serum thyroglobulin levels in 7 out of 10 patients, indicating a positive response to the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locoregional control of metastatic well-differentiated thyroid cancer by ultrasound-guided radiofrequency ablation. Baek, JH., Kim, YS., Sung, JY., et al.[2022]

Ultrasound-guided radiofrequency ablation is a safe and effective non-invasive treatment for benign thyroid nodules that are at least 2 cm in size and less than 20 ml in volume.

The treatment is well-supported by current literature, demonstrating high efficacy, safety, patient satisfaction, and cost-effectiveness, and it also shows promise as an alternative therapy for hyperfunctioning nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ultrasound-guided radiofrequency ablation of benign symptomatic thyroid nodules]. Larsen, KD., Håkansson, K., Papesch, M., et al.[2021]

Radiofrequency ablation (RFA) is a safe and effective non-surgical treatment for benign thyroid nodules, with long-term results showing significant volume reduction of nodules.

While RFA has a low risk of major complications (up to 3.8%), careful management of both minor and major complications is essential, and long-term follow-up is necessary to monitor for potential regrowth of nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thyroid Nodule Radiofrequency Ablation: Complications and Clinical Follow Up. Lim, JY., Kuo, JH.[2022]

Radiofrequency ablation (RFA) is an effective treatment for benign thyroid nodules, achieving an average volume reduction of 74.51% within one year based on a study of 116 patients with 137 nodules.

Pre-ablation ultrasound characteristics, particularly cyst composition, can help predict treatment success, and post-ablation ultrasound changes may lead to misinterpretation of nodules as potentially malignant, highlighting the need for careful follow-up imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in the ultrasonographic appearance of thyroid nodules after radiofrequency ablation. Wu, MH., Chen, KY., Chen, A., et al.[2021]

Radiofrequency ablation (RFA) significantly reduced the volume of benign thyroid nodules, with the most substantial reductions seen in smaller nodules, decreasing from an average of 24.5 mL to 8.6 mL after 6 months.

RFA improved cosmetic outcomes for all treated patients and alleviated pressure symptoms in medium and large nodules, while untreated nodules showed no volume change and worsened symptoms over the same period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study of effectiveness of ultrasound-guided radiofrequency ablation versus control group in patients affected by benign thyroid nodules. Cesareo, R., Pasqualini, V., Simeoni, C., et al.[2015]

Radiofrequency ablation (RFA) is safe and effective for treating bilateral thyroid nodules, achieving a mean volume reduction rate of 64% after 6 months in a single-setting treatment of 6 patients.

The safety profile of RFA remains strong, with no reported complications in both the single-setting cohort and a control group treated in a separate setting, suggesting its viability for managing multiple nodules simultaneously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral nodule radiofrequency ablation in a single setting: First reported case series. Issa, PP., Magazine, BM., LaForteza, A., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Successful radiofrequency ablation strategies for benign thyroid nodules. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Effect of ultrasound parameters of benign thyroid nodules on radiofrequency ablation efficacy. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Predictor Analysis in Radiofrequency Ablation of Benign Thyroid Nodules: A Single Center Experience. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Locoregional control of metastatic well-differentiated thyroid cancer by ultrasound-guided radiofrequency ablation. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

[Ultrasound-guided radiofrequency ablation of benign symptomatic thyroid nodules]. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Thyroid Nodule Radiofrequency Ablation: Complications and Clinical Follow Up. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Differences in the ultrasonographic appearance of thyroid nodules after radiofrequency ablation. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Prospective study of effectiveness of ultrasound-guided radiofrequency ablation versus control group in patients affected by benign thyroid nodules. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Bilateral nodule radiofrequency ablation in a single setting: First reported case series. [2023]