Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

NCT04129411 | Completed Results DMC FDA Device

• 1 other identifier: 19-005486
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Papillary Thyroid Cancer; Papillary Thyroid Microcarcinoma

Keywords

RFA; Radiofrequency; Thyroid Cancer; Ablation techniques; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Changes in Thyroid Nodule Size

  Thyroid tumor volume shrinkage will be assessed by ultrasound and compared with pre-procedure volume (measure in mL)

  24 months

Secondary Outcomes (5)

• Pain Related to RFA Procedure

  Up to 24 months

• Development of Lymph Node Involvement

  18 months

• Development of Distant Metastasis

  18 months

• Safety of the RFA Procedure

  Up to 24 months

• Change in Thyroid Status

  Up to 24 months

Study Arms (1)

RFA Group

EXPERIMENTAL

Device: RFA

Interventions

RFA DEVICE

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

RFA Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Thyroid Cancer, Papillary; Papillary Thyroid Microcarcinoma; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Results Point of Contact

• Title: Dr. Marius Stan
• Organization: Mayo Clinic

stan.marius@mayo.edu

507-284-2463

Study Officials

• Marius Stan, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label single interventional series

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 16, 2019
• Study Start: June 15, 2020
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)