The Safety and Feasibility of Radiofrequency Ablation to Treat Low-risk Thyroid Cancer

NCT06929650 | Recruiting

• 1 other identifier: 21-5788
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test radiofrequency ablation (RFA) in thyroid cancers ≤2 cm in diameter. The main question it aims to answer is: • What is the feasibility of RFA use for low-risk thyroid cancers (≤2 cm)? Participants will undergo a set of pre-procedural scans of the target thyroid nodule and undergo the RFA procedure/intervention. Then, participants will partake in three follow-up appointments at 4 weeks, 6 months, and 12 months post-procedure as per standard of care.

Conditions

Thyroid Nodule; Thyroid Cancer

Keywords

Radiofrequency Ablation; Feasibility; Adverse Event; Thyroid nodule

Outcome Measures

Primary Outcomes (1)

• Complications

  Rate of complications, including pain, burns, recurrent laryngeal nerve palsy, hematoma, nodule rupture, and deviation from euthyroidism

  Immediately after the procedure, and 4 weeks/6 months/12 months post-procedure.

Secondary Outcomes (7)

• Effectiveness

  4 weeks/6 months/12 months post-procedure.

• Effectiveness

  4 weeks/6 months/12 months post-procedure.

• Effectiveness

  4 weeks/6 months/12 months post-procedure.

• Quality of life

  7-9 months post-procedure.

• Quality of life

  7-9 months post-procedure.

Study Arms (1)

Intervention

EXPERIMENTAL

Participants receive RFA intervention for thyroid nodule.

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablation PROCEDURE

Radiofrequency energy is delivered to the thyroid nodule via the medical device. This device is a system consisting of 3 main components: 1. VIVA combo RF system (generator and pump) 2. single foot switch 3. electrode (5mm, 7mm, 10mm, or adjustable).

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with:
• Nodule less than or equal to 2cm in size
• a. Specifically: Bethesda 5/6
• Their age is ≥18 years and ≤100 years
• Able to provide written consent
• Able to attend required follow-ups as per the protocol

You may not qualify if:

• Patients \<18 years old
• Pregnant women
• Any concern for invasive or metastatic thyroid cancer
• Previously treated for thyroid cancer

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2C4, Canada

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jesse D Pasternak, MD, MPH

  University Health Network (UHN) Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesse Pasternak

CONTACT

(416) 340-4792; jesse.pasternak@uhn.ca

Emily Saso

CONTACT

emily.saso@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 16, 2025
• Study Start: April 20, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)