Papillary Thyroid CancerNCT04129411
Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation
A study testing RFA in people with Papillary Thyroid Cancer and Papillary Thyroid Microcarcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
Investigators intend to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Papillary Thyroid Cancer, Papillary Thyroid Microcarcinoma
- What is being tested?
- RFA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 7 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are adults
- Nodule with Papillary thyroid carcinoma meeting the below criteria:
- Diagnosed by fine needle aspiration (FNA) cytology.
- Size < 1.5 cm
- Non-surgical therapy is considered acceptable by the treating physician
- Radiology evaluation deems the lesion amenable to RFA therapy with minimal risk of complication
Who cannot join
- Clinical evidence for a multifocal papillary thyroid malignancy
- Clinical evidence for local or distant metastatic disease
- Pregnancy
- Vocal cord paralysis on contralateral side
- Coagulopathy or patients on anticoagulation therapy
- Patients with prior neck surgery or neck radiation
Show all 10Show fewer
- Patients with neck anatomy that precludes easy access by RFA
- Patients with comorbidities deemed too high of a risk for general anesthesia
- Treatment with another investigational drug or intervention (within 6 weeks of planned RFA).
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study for the Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation
Investigators intend to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.
Read the detailed description
Investigators plan to identify patients with small papillary thyroid carcinoma and subject such patients to radiofrequency ablation (RFA) therapy.
Following RFA procedure patients will be monitored to study the changes in primary tumor volume, development of lymph node involvement, development of distant metastasis and changes in serum thyroid hormone levels.
Investigators will also assess the stability of these changes (need for repeat therapy) and the safety of the RFA procedure.
- Being tested
- RFA
- Keywords
- RFA, Radiofrequency, Thyroid Cancer, Ablation techniques, Ultrasonography
- Medical subject headings
- Thyroid Cancer, Papillary, Papillary Thyroid Microcarcinoma, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFADevice
Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.
| Study group | Role | What they receive |
|---|---|---|
| RFA Group | Experimental | Not described Receives: Device: RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Thyroid Nodule Size
Thyroid tumor volume shrinkage will be assessed by ultrasound and compared with pre-procedure volume (measure in mL)
Measured: 24 months
Secondary outcomes (5)
Pain Related to RFA Procedure
Assessed by number of participants that reported any pain related to RFA procedure
Measured: Up to 24 months
Development of Lymph Node Involvement
Assessed by the number of participants with cervical adenopathy (enlargement of lymph nodes in the neck area). Participants will be evaluated during follow-up visits.
Measured: 18 months
Development of Distant Metastasis
Assessed by the number of participants with distant metastasis if regional neck metastasis is detected on follow up.
Measured: 18 months
Safety of the RFA Procedure
Assessed by the number of participants who experienced infection, hematoma, bruising, or other complications at the RFA site.
Measured: Up to 24 months
Change in Thyroid Status
Participants were tracked for thyroid status following radiofrequency ablation
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start15 Jun 2020
- Primary completion7 May 2024
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Papillary Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label single interventional series
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marius Stan, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129411
- Sponsor's protocol ID
- 19-005486
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2019
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT04129411
- Acronym / sponsor ID
- 19-005486
- Keywords
- RFA, Radiofrequency, Thyroid Cancer, Ablation techniques, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Posted 20 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators intend to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.
Detailed description
Investigators plan to identify patients with small papillary thyroid carcinoma and subject such patients to radiofrequency ablation (RFA) therapy.
Following RFA procedure patients will be monitored to study the changes in primary tumor volume, development of lymph node involvement, development of distant metastasis and changes in serum thyroid hormone levels.
Investigators will also assess the stability of these changes (need for repeat therapy) and the safety of the RFA procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label single interventional series
| Arm | Type | Receives |
|---|---|---|
| RFA Group | Experimental | Device: RFA |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are adults
- Nodule with Papillary thyroid carcinoma meeting the below criteria:
Key exclusion criteria (10 listed)
- Clinical evidence for a multifocal papillary thyroid malignancy
- Clinical evidence for local or distant metastatic disease
- Pregnancy
- Vocal cord paralysis on contralateral side
- Coagulopathy or patients on anticoagulation therapy
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 |
|---|---|---|
| RFARadiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer. | Device | RFA Group |
Primary outcome
Changes in Thyroid Nodule Size
Time frame: 24 months
Thyroid tumor volume shrinkage will be assessed by ultrasound and compared with pre-procedure volume (measure in mL)
5 secondary outcomes
Pain Related to RFA Procedure
Time frame: Up to 24 months
Development of Lymph Node Involvement
Time frame: 18 months
Development of Distant Metastasis
Time frame: 18 months
Safety of the RFA Procedure
Time frame: Up to 24 months
Change in Thyroid Status
Time frame: Up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Papillary Thyroid Cancer
Recruiting
Active Surveillance of Papillary Thyroid Microcarcinoma
Papillary Thyroid Microcarcinoma
RecruitingObservational study
Definition of Mutational Profile of Papillary Thyroid Tumors by Mass-ARRAY
Papillary Thyroid Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Active, not recruitingPhase 3
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
Differentiated Thyroid Cancer
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.
Marius Stan, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFA in people with Papillary Thyroid Cancer and Papillary Thyroid Microcarcinoma, run by Mayo Clinic 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 20 May 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?
Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 24 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 20 May 2025.