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Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04129411
Recruitment Status : Not yet recruiting
First Posted : October 16, 2019
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Marius Stan, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Papillary Thyroid Cancer Papillary Thyroid Microcarcinoma Device: RFA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label single interventional series
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study for the Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation
Estimated Study Start Date : January 15, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arm Intervention/treatment
Experimental: RFA Group Device: RFA
Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.




Primary Outcome Measures :
  1. Changes in thyroid nodule size (overall volume measured in percentage) [ Time Frame: 18 months ]
    Thyroid tumor volume shrinkage in percentage will be assessed by ultrasound and compared with pre-procedure volume.


Secondary Outcome Measures :
  1. Pain related to RFA procedure [ Time Frame: 1-2 months ]
    McGill Pain Questionnaire (Pain intensity scale: 0 = none, 1 = mild, 2 = moderate or 3 = severe)

  2. Development of lymph node involvement [ Time Frame: 18 months ]
    Cervical adenopathy

  3. Development of distant metastasis [ Time Frame: 18 months ]
    Distant metastatic sites

  4. Safety of the RFA procedure [ Time Frame: 1-2 months ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129411


Contacts
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Contact: Marius Stan, MD 507-284-2463 stan.marius@mayo.edu
Contact: Vishakantha Murthy, PhD., MBA 507-255-8112 Murthy.Vishakantha@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Contact: Marius Stan, MD    507-284-2463    stan.marius@mayo.edu   
Contact: Vishakantha Murthy, PhD., MBA    507-255-8112    Murthy.Vishakantha@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Marius Stan, MD Mayo Clinic

Additional Information:
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Responsible Party: Marius Stan, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04129411    
Other Study ID Numbers: 19-005486
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Marius Stan, Mayo Clinic:
RFA
Radiofrequency
Thyroid Cancer
Ablation techniques
Ultrasonography
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Adenocarcinoma, Papillary
Adenocarcinoma