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Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

Primary Purpose

Papillary Thyroid Cancer, Papillary Thyroid Microcarcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RFA
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papillary Thyroid Cancer focused on measuring RFA, Radiofrequency, Thyroid Cancer, Ablation techniques, Ultrasonography

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Are adults

  • Nodule with Papillary thyroid carcinoma meeting the below criteria:

    • Diagnosed by 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.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RFA Group

Arm Description

Outcomes

Primary Outcome Measures

Changes in thyroid nodule size (overall volume measured in percentage)
Thyroid tumor volume shrinkage in percentage will be assessed by ultrasound and compared with pre-procedure volume.

Secondary Outcome Measures

Pain related to RFA procedure
McGill Pain Questionnaire (Pain intensity scale: 0 = none, 1 = mild, 2 = moderate or 3 = severe)
Development of lymph node involvement
Cervical adenopathy
Development of distant metastasis
Distant metastatic sites
Safety of the RFA procedure
Evaluation of site of RFA for local complication and asses pain with McGill Pain Questionnaire (Pain intensity scale: 0 = none, 1 = mild, 2 = moderate or 3 = severe)

Full Information

First Posted
October 4, 2019
Last Updated
May 4, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04129411
Brief Title
Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation
Official Title
Pilot Study for the Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Thyroid Cancer, Papillary Thyroid Microcarcinoma
Keywords
RFA, Radiofrequency, Thyroid Cancer, Ablation techniques, Ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open label single interventional series
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RFA Group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
RFA
Intervention Description
Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.
Primary Outcome Measure Information:
Title
Changes in thyroid nodule size (overall volume measured in percentage)
Description
Thyroid tumor volume shrinkage in percentage will be assessed by ultrasound and compared with pre-procedure volume.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Pain related to RFA procedure
Description
McGill Pain Questionnaire (Pain intensity scale: 0 = none, 1 = mild, 2 = moderate or 3 = severe)
Time Frame
1-2 months
Title
Development of lymph node involvement
Description
Cervical adenopathy
Time Frame
18 months
Title
Development of distant metastasis
Description
Distant metastatic sites
Time Frame
18 months
Title
Safety of the RFA procedure
Description
Evaluation of site of RFA for local complication and asses pain with McGill Pain Questionnaire (Pain intensity scale: 0 = none, 1 = mild, 2 = moderate or 3 = severe)
Time Frame
1-2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are adults Nodule with Papillary thyroid carcinoma meeting the below criteria: Diagnosed by 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Stan, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

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