Benign Thyroid Gland NeoplasmNCT05003856
Radiofrequency Ablation for the Treatment of Benign or Low Risk Thyroid Nodule
A study testing Quality-of-Life Assessment and Radiofrequency Ablation in people with Benign Thyroid Gland Neoplasm and Recurrent Thyroid Gland Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Thyroid Gland Neoplasm, Recurrent Thyroid Gland Carcinoma, Thyroid Gland Follicular Tumor of Uncertain Malignant Potential
- What is being tested?
- Quality-of-Life Assessment and Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2022to 27 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 agrees to participate in the clinical study and to complete all required visits and evaluations
- Negative serum or urine pregnancy test for females of childbearing potential at base line pre-procedure evaluation
Who cannot join
- Patients with cardiac arrhythmia and/or implanted cardiac device
- Hyper-functioning nodules, evaluated by thyroid function test and/or 99mTc-pertechnetate scintigraphic findings
- History of neck radiation therapy
- Pregnancy
- Allergies to medications for anesthesia
- Primary thyroid PTC with aggressive histology (tall cell, columnar cell, insular, e.g.) in consultation with cytology, endocrine and surgery team
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- Extra-thyroidal invasion of PTC OR local nodal/distant systemic metastatic disease
- Cystic nodules (< 70% solid components)
- Calcified nodules
- Targeted nodule within 0.5 cm from the major vessels, vagus nerve, brachial plexus, and recurrent laryngeal nerve
- Patients with contralateral vocal cord paralysis
- Uncorrectable coagulopathy with partial thromboplastin time (PTT) > 1.5 x upper limit of normal (ULN) or international normalized ratio (INR) > 1.5 or platelet count <100,000 per mm^3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiofrequency Ablation Use in Thyroid Nodule
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate the longitudinal thyroid nodule volume changes induced by radiofrequency ablation (RFA) during post procedure follow-up.
SECONDARY OBJECTIVES:
- Evaluate treatment response to compressive and/or cosmetic symptoms that affect patient's quality of life.
II. Evaluate the sonographic features of the nodule induced by RFA.
III. Compare cost of ultrasound guided RFA to gold standard surgical thyroidectomy.
OUTLINE:
Patients undergo ultrasound guided RFA over 1-2 hours.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.
- Conditions
- Benign Thyroid Gland Neoplasm, Recurrent Thyroid Gland Carcinoma, Thyroid Gland Follicular Tumor of Uncertain Malignant Potential, Thyroid Gland Nodule, Thyroid Gland Papillary Carcinoma
- Being tested
- Quality-of-Life Assessment, Radiofrequency Ablation
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule, Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Radiofrequency AblationProcedure or surgery
Also called Ablation, Radiofrequency, Radiofrequency Interstitial Ablation, RFA
Undergo RFA
| Study group | Role | What they receive |
|---|---|---|
| Treatment (RFA) | Experimental | Patients undergo ultrasound guided RFA over 1-2 hours. Receives: Other: Quality-of-Life Assessment; Procedure: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in thyroid nodule size
The change from baseline to follow-up will be evaluated using Wilcoxon signed-rank tests. Additionally, will assess the association between changes in the nodule volume and covariates of interest, including but not excluded to the percentage of volume ablated, the nodule composition at treatment and follow-up, and the amount of energy delivered in Joules.
Measured: Baseline up to 12 months
Secondary outcomes (3)
Treatment response that affect quality of life
Will compare symptom scores and cosmetic grades to baseline using Wilcoxon signed-rank tests at both 6 months and at 12 months of follow-up.
Measured: Up to 12 months post-treatment
Sonographic features of nodules
Sonographic features will be summarized descriptively.
Measured: Up to 12 months post-treatment
Cost of ultrasound-guided radiofrequency ablation (RFA)
The cost of ultrasound-guided RFA will be summarized. Comparisons may be made with historical data on the costs associated with surgical thyroidectomy.
Measured: Up to 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start29 Aug 2022
- Primary completion27 Mar 2025
- Study completion27 Mar 2025
Why it stopped: Administrativley Complete, 75%\<Participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Thyroid Gland NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim O Learned, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003856
- Sponsor's protocol ID
- 2021-0542
- Other IDs
- NCI-2021-08354, 2021-0542
- Status last verified
- Mar 2025
- First submitted
- 5 Aug 2021
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation Use in Thyroid Nodule
- ClinicalTrials.gov ID
- NCT05003856
- Acronym / sponsor ID
- 2021-0542
- Conditions
- Benign Thyroid Gland Neoplasm, Recurrent Thyroid Gland Carcinoma, Thyroid Gland Follicular Tumor of Uncertain Malignant Potential, Thyroid Gland Nodule, Thyroid Gland Papillary Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrativley Complete, 75%\<Participants
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- Evaluate the longitudinal thyroid nodule volume changes induced by radiofrequency ablation (RFA) during post procedure follow-up.
SECONDARY OBJECTIVES:
- Evaluate treatment response to compressive and/or cosmetic symptoms that affect patient's quality of life.
II. Evaluate the sonographic features of the nodule induced by RFA.
III. Compare cost of ultrasound guided RFA to gold standard surgical thyroidectomy.
OUTLINE:
Patients undergo ultrasound guided RFA over 1-2 hours.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (RFA) | Experimental | Other: Quality-of-Life Assessment, Procedure: Radiofrequency AblationPatients undergo ultrasound guided RFA over 1-2 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- Patients with cardiac arrhythmia and/or implanted cardiac device
- Hyper-functioning nodules, evaluated by thyroid function test and/or 99mTc-pertechnetate scintigraphic findings
- History of neck radiation therapy
- Pregnancy
- Allergies to medications for anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (RFA) |
| Radiofrequency AblationAlso: Ablation, Radiofrequency, Radiofrequency Interstitial Ablation, RFAUndergo RFA | Procedure or surgery | Treatment (RFA) |
Primary outcome
Changes in thyroid nodule size
Time frame: Baseline up to 12 months
The change from baseline to follow-up will be evaluated using Wilcoxon signed-rank tests. Additionally, will assess the association between changes in the nodule volume and covariates of interest, including but not excluded to the percentage of volume ablated, the nodule composition at treatment and follow-up, and the amount of energy delivered in Joules.
3 secondary outcomes
Treatment response that affect quality of life
Time frame: Up to 12 months post-treatment
Sonographic features of nodules
Time frame: Up to 12 months post-treatment
Cost of ultrasound-guided radiofrequency ablation (RFA)
Time frame: Up to 12 months post-treatment
Results and safety
The study was stopped early (reason given: Administrativley Complete, 75%\<Participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim O Learned principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality-of-Life Assessment and Radiofrequency Ablation in people with Benign Thyroid Gland Neoplasm and Recurrent Thyroid Gland Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Administrativley Complete, 75%\<Participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in thyroid nodule size (time frame: Baseline up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.