Radiofrequency Ablation for Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Carcinoma+10 More
Radiofrequency Ablation - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether radiofrequency ablation is as effective as surgery for treating benign or low risk thyroid nodules.

See full description

Eligible Conditions

  • Carcinoma
  • Benign Thyroid Gland Neoplasm
  • Recurrent Thyroid Gland Carcinoma
  • Thyroid Gland Nodule
  • Thyroid Gland Papillary Carcinoma
  • Thyroid Gland Follicular Tumor of Uncertain Malignant Potential

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Radiofrequency Ablation will improve 1 primary outcome and 3 secondary outcomes in patients with Carcinoma. Measurement will happen over the course of Up to 12 months post-treatment.

Month 12
Changes in thyroid nodule size
Month 12
Cost of ultrasound-guided radiofrequency ablation (RFA)
Sonographic features of nodules
Treatment response that affect quality of life

Trial Safety

Trial Design

1 Treatment Group

Treatment (RFA)
1 of 1
Experimental Treatment

This trial requires 100 total participants across 1 different treatment group

This trial involves a single treatment. Radiofrequency Ablation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Treatment (RFA)Patients undergo ultrasound guided RFA over 1-2 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiofrequency Ablation
2013
Completed Phase 4
~1040

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline up to 12 months for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma or one of the other 10 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patient is older than 18 years, is not a surgical candidate or refuses to have surgery
Patient is medically fit to undergo local anesthesia with or without conscious sedation
Patient is able to understand and give consent to participation in the study
Presence of compression symptoms or cosmetic concerns for which patient request treatment of the benign thyroid nodule
Solitary thyroid nodule or dominating nodule that is well-defined in multinodular goiter
Benign nodule is >= 2 cm in the largest dimension, and has either solid, or predominantly solid composition (>= 70% volume) without large calcification. Nodule is confirmed as benign (Bethesda II) on at least 2 ultrasound guided fine needle aspirations (FNA) or core needle biopsy (CNB) or a single benign diagnosis of FNA or CNB when the nodule has benign ultrasound features (American College of Radiology [ACR] Thyroid Imaging Reporting & Data System [TI-RAD] TR 1-3, American Thyroid Association [ATA] very low suspicion) within 6 months of planned RFA
Indeterminate thyroid nodule (atypical cells of undetermined significance [ACUS], follicular neoplasm), papillary thyroid carcinoma (PTC) without metastasis or locally recurrent thyroid cancer < 2 cm in the largest dimension. Nodule cytology is confirmed on a single FNA or CNB when the nodule has concordant ultrasound features (ACR TI-RAD TR 4-5, ATA intermediate-high suspicion) within 6 months of planned RFA
Entirety of the selected nodule is visible on ultrasound without significant extension posterior to trachea or mediastinal component
Selected nodule is amenable to trans-isthmus approach
Normal complete blood count, blood coagulation, serum levels of thyroid hormones, thyrotropin (TSH), calcitonin, and absence of anti-thyroglobulin antibodies (TgAb) and anti-thyroid peroxidase antibodies (TPOAb)

Patient Q&A Section

How does radiofrequency ablation work?

"The data from this study support the hypothesis that RFA works primarily through cellular death rather than thermal effects. It seems that the heat generated during RFA is not sufficient to kill cells. However, cell death may occur via necrosis and apoptosis pathways. Further evaluation of the mechanisms of RFA is necessary to improve our understanding of its efficacy." - Anonymous Online Contributor

Unverified Answer

What are common treatments for thyroid nodule?

"Ultrasonography is used by most clinicians to diagnose thyroid nodules. A biopsy is often performed after ultrasound when the diagnosis is uncertain or because other tests have failed to provide conclusive results. Most patients (63%) receive one treatment at first. The decision whether to remove or observe the nodule depends on the risk of malignancy. Follow-up is important especially if suspicious symptoms develop. Fusion therapy, which combines radioactive iodine with anti-thyroid medication, may be helpful in follicular carcinoma. If follicular carcinoma is diagnosed, surgery is the only definitive treatment. In contrast, papillary carcinoma can usually be treated with total thyroidectomy alone without chemotherapy." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in radiofrequency ablation for therapeutic use?

"RF ablation is an effective and safe modality for treating thyroid nodules. It has become one of the standard treatments for benign thyroid nodules and in patients who refuse surgery. However, there are a number of important risks involved with this therapy, although they are minimized when performed correctly. Patients should be informed well about the risks and benefits of RF ablation." - Anonymous Online Contributor

Unverified Answer

How many people get thyroid nodule a year in the United States?

"Thyroid nodules should be diagnosed carefully in all cases. On average more than 4% of the population will have thyroid nodules at some point in their life. The prevalence of thyroid nodules seems to be increasing over time." - Anonymous Online Contributor

Unverified Answer

How serious can thyroid nodule be?

"Thyroid nodule is not always an ominous diagnosis. It can be treated safely without surgery. However, the benign and malignant nodules should be differentiated carefully. If there are any doubts about the benign nodule, surgical resection might be needed." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving radiofrequency ablation?

"This review shows that RF ablation is a feasible and safe procedure for treating thyroid nodules. However, there have not been any randomized controlled clinical trials comparing RF ablation against medical therapy alone. A large prospective study comparing the two methods of management would be very beneficial." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for thyroid nodule?

"Thyroid nodules should be evaluated prior to treatment, especially in children, as the nodular growth may affect the outcome of the patient. The nodule size and the ultrasound feature (i.e. echogenicity) at presentation was found to be significant predictors of malignancy. In our series, the nodule size (<2 cm) had a significantly higher risk of malignancy than nodules larger than 2 cm. More studies need to be done to confirm these results." - Anonymous Online Contributor

Unverified Answer

How quickly does thyroid nodule spread?

"Thyroid tumors were first detected in approximately 4% of the patients at an average age of 50; most of them were benign. Thyroid cancer was found in about 3% of the patients, which included follicular adenoma (10%), medullary carcinoma (5%), and papillary carcinoma (90%). The mean time interval from the first onset of symptoms until the final diagnosis of malignancy was 6.8 +/- 1.3 yr. In our study, there were no significant differences among the groups regarding the number of nodes removed, the size of the tumor, or the presence of distant metastases." - Anonymous Online Contributor

Unverified Answer

What is the latest research for thyroid nodule?

"The majority of thyroid nodules are benign. Thyroid nodules should be biopsied if they are larger than 1 cm in size, have coarse calcifications on imaging, or produce symptoms. Ultrasonography has replaced fine needle aspiration for most cases. In the setting of diagnostic uncertainty between follicular neoplasm and residual nodal tissue, the final diagnosis is based on histopathologic characteristics. Cytopathologists are still best at diagnosing follicular neoplasms, but nuclear pathologists are better at distinguishing follicular neoplasms from residual nodal tissue. Most thyroid nodules that are biopsied prove to be follicular neoplasms." - Anonymous Online Contributor

Unverified Answer

What are the signs of thyroid nodule?

"The presentation of thyroid nodules varies depending on size and type. Thyroid nodules that are 5 to 10 cm in diameter often present as a 'cold' nodule, which means it has no pain or tenderness and is not palpable at palpation. In contrast, larger nodules may cause neck pressure due to enlargement of the larynx resulting in difficulty swallowing, talking, or breathing. Nodules that are smaller (<2 cm) are more likely to be associated with thyroid disease and will often cause the nodule to become tender and mobile when pressed." - Anonymous Online Contributor

Unverified Answer

Has radiofrequency ablation proven to be more effective than a placebo?

"RFA proved to be more effective than a placebo with respect to decreasing thyroid nodule size and improving cosmetic appearance after 6 months follow up. Furthermore, patients who were treated with RFA had better quality of life scores compared to the control group. Occasionally, RFA was associated with some complications including hematoma formation and hemoptysis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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