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Procedure
Radiofrequency Ablation for Thyroid Nodules
N/A
Recruiting
Led By Kim O Learned
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is able to understand and give consent to participation in the study
Patient is older than 18 years, is not a surgical candidate or refuses to have surgery
Must not have
Allergies to medications for anesthesia
Extra-thyroidal invasion of PTC OR local nodal/distant systemic metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial studies radiofrequency ablation to treat patients with benign or low-risk thyroid nodules. The goal is to learn if it is as effective as surgery and if it has a better recovery response.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of RFA may include pain at the site of treatment, swelling, bruising, infection risk at the needle insertion point, temporary voice changes due to nerve irritation near the thyroid gland.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand and agree to participate in the study.
Select...
I am over 18 and cannot or will not have surgery.
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I have a single thyroid nodule or a dominant one in a multinodular goiter.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic to some anesthesia medications.
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My thyroid cancer has spread beyond the thyroid or to other parts of my body.
Select...
My targeted nodule is close to major blood vessels or important nerves.
Select...
My thyroid cancer is of an aggressive type, confirmed by a team of specialists.
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I have had radiation therapy to my neck.
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I have a heart rhythm problem or a device like a pacemaker.
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My thyroid nodules are overactive, confirmed by tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 12 months
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
Secondary study objectives
Cost of ultrasound-guided radiofrequency ablation (RFA)
Sonographic features of nodules
Treatment response that affect quality of life
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: Treatment (RFA)Experimental Treatment2 Interventions
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
~740
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,124 Total Patients Enrolled
Kim O LearnedPrincipal InvestigatorM.D. Anderson Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Women who can have babies must have a negative pregnancy test before starting the study.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.My targeted nodule is close to major blood vessels or important nerves.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.I want treatment for my thyroid nodule due to discomfort or appearance concerns.The entire nodule can be seen on ultrasound, and it doesn't extend too far behind the trachea or into the mediastinum.My thyroid nodule is suspicious but not clearly cancerous, or I have a small, local thyroid cancer without spread.My nodule can be reached through a specific surgical approach.I understand and agree to participate in the study.I am over 18 and cannot or will not have surgery.My thyroid cancer is of an aggressive type, confirmed by a team of specialists.Your blood does not clot properly, or your platelet count is too low.I am healthy enough for local anesthesia with or without sedation.I have a single thyroid nodule or a dominant one in a multinodular goiter.I have had radiation therapy to my neck.I have a heart rhythm problem or a device like a pacemaker.My thyroid nodules are overactive, confirmed by tests.You have calcified nodules.You have paralysis in your vocal cords on the opposite side of your body.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (RFA)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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