Clinical trial NCT06929650: The Safety and Feasibility of Radiofrequency Ablation to Treat Low-risk Thyroid Cancer
Official title: Thermo-Ablation With Radiofrequency Medical Technologies to Treat Thyroid Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Nodule
Thyroid Cancer
Keywords: Radiofrequency Ablation
Feasibility
Adverse Event
Thyroid nodule
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Complications
timeFrame: Immediately after the procedure, and 4 weeks/6 months/12 months post-procedure.
Secondary outcomes:
measure: Effectiveness
timeFrame: 4 weeks/6 months/12 months post-procedure.
measure: Effectiveness
timeFrame: 4 weeks/6 months/12 months post-procedure.
measure: Effectiveness
timeFrame: 4 weeks/6 months/12 months post-procedure.
measure: Quality of life
timeFrame: 7-9 months post-procedure.
measure: Quality of life
timeFrame: 7-9 months post-procedure.
measure: Quality of life
timeFrame: 7-9 months post-procedure.
measure: Quality of life
timeFrame: 7-9 months post-procedure.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network (UHN) Toronto
name: Jesse D Pasternak, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: