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Completed

NCT Number: NCT04129411

Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RFA

Device

Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Pain Related to RFA Procedure

    Time frame: Up to 24 months

    Assessed by number of participants that reported any pain related to RFA procedure

  2. Development of Lymph Node Involvement

    Time frame: 18 months

    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.

  3. Development of Distant Metastasis

    Time frame: 18 months

    Assessed by the number of participants with distant metastasis if regional neck metastasis is detected on follow up.

  4. Safety of the RFA Procedure

    Time frame: Up to 24 months

    Assessed by the number of participants who experienced infection, hematoma, bruising, or other complications at the RFA site.

  5. Change in Thyroid Status

    Time frame: Up to 24 months

    Participants were tracked for thyroid status following radiofrequency ablation

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Pilot Study for the Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 16, 2019
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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