Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

NCT ID: NCT04129411

Last Updated: 2025-05-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2024-05-07

Brief Summary

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Investigators intend to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.

Detailed Description

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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.

Conditions

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Papillary Thyroid Cancer Papillary Thyroid Microcarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label single interventional series
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RFA Group

Group Type EXPERIMENTAL

RFA

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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19-005486

Identifier Type: -

Identifier Source: org_study_id

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