Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation
NCT ID: NCT04129411
Last Updated: 2025-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2020-06-15
2024-05-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RFA Group
RFA
Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.
Interventions
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RFA
Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Marius Stan, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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19-005486
Identifier Type: -
Identifier Source: org_study_id
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