The Safety and Feasibility of Radiofrequency Ablation to Treat Low-risk Thyroid Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiofrequency ablation.
- Who it may be relevant to
- Registry conditions: Thyroid Nodule, Thyroid Cancer. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Thermo-Ablation With Radiofrequency Medical Technologies to Treat Thyroid Cancers
Overview
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.
Interventions
- Procedure 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).
Primary outcome measures
- Complications [Time frame: Immediately after the procedure, and 4 weeks/6 months/12 months post-procedure.]
Secondary outcome measures (7)
- Effectiveness [Time frame: 4 weeks/6 months/12 months post-procedure.]
- Effectiveness [Time frame: 4 weeks/6 months/12 months post-procedure.]
- Effectiveness [Time frame: 4 weeks/6 months/12 months post-procedure.]
- Quality of life [Time frame: 7-9 months post-procedure.]
- Quality of life [Time frame: 7-9 months post-procedure.]
- Quality of life [Time frame: 7-9 months post-procedure.]
- Quality of life [Time frame: 7-9 months post-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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- University Health Network — Toronto
Identifiers
NCT: NCT06929650 · 21-5788