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

NCT ID: NCT06929650

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2025-12-31

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.

Detailed Description

This is a single center, prospective case series designed to assess the feasibility of RFA therapy (using an investigational RFA device) in a small cohort of participants at University Health Network Toronto. We hypothesize that it will be safe and feasible to use RFA therapy at the University Health Network, Toronto. Further, we believe participants will maintain a good quality of life in the postoperative period, including most avoiding hypothyroidism.

Patients will follow the standard clinical work-up to undergo surgery (e.g. lab parameters and preoperative scans). Patients will - after written informed consent - undergo the RFA procedure.

Within the first year there will be three follow-ups with the participants at:

• 4 weeks
• 6 months
• 12 months post-procedure. After the 12-month follow-up, participants will have follow-up appointments every 6 months until the end of the study.

During these follow-up appointments, the clinician will note any complications or adverse events, and participants will undergo blood sample draws to evaluate serum thyroid stimulating hormone (TSH) concentration. Thyroid nodule size is captured at each follow-up post-procedure via ultrasound, and a re-biopsy may be performed after 12 months to determine if there is material change in the cellular type of the thyroid nodule.

Cost of RFA treatment (probes, human resources, clinic time, complications) compared to traditional thyroidectomy (instruments, human resources, operating room time, hospital stay, complications) will also be compared to historical controls for thyroidectomy costs based on past literature to evaluate the feasibility of RFA as an intervention in this population.

Patients will be given a questionnaire at baseline and post-RFA (~7-9 months) which includes the following components:

• thyroid cancer treatment status;
• the Decision Regret Scale (0 to 100) where 100 represents maximal regret (only post-RFA);
• the Fear of Progression Questionnaire- Short Form questionnaire (focused on thyroid cancer disease progression);
• the Hospital Anxiety and Depression Scale (HADS);
• the MD Anderson Symptom Inventory for thyroid cancer (MDASI-Thy), a disease-specific quality of life questionnaire; and
• the Body Image Scale (BIS), a questionnaire on body image perception for cancer patients.

Conditions

Thyroid Nodule; Thyroid Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Participants receive RFA intervention for thyroid nodule.

Group Type: EXPERIMENTAL

Radiofrequency ablation

Intervention Type: 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).

Interventions

Radiofrequency ablation

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 Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Jesse Pasternak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesse D Pasternak, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University Health Network (UHN) Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jesse Pasternak

Role: CONTACT

jesse.pasternak@uhn.ca

(416) 340-4792

Emily Saso

Role: CONTACT

emily.saso@uhn.ca

Facility Contacts

Ilhaan Abdulle

Role: primary

ilhaan.abdulle@uhn.ca

(416) 340-4792

Emily Saso

Role: backup

emily.saso@uhn.ca

(613) 854-4420

Other Identifiers

21-5788

Identifier Type: -

Identifier Source: org_study_id