Thermo-Ablation With Radiofrequency Medical Technologies to Treat Thyroid Cancers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Complications
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
Intervention
Participants receive RFA intervention for thyroid nodule.
Intervention: Radiofrequency ablation (Procedure)
Outcomes
Primary Outcomes
Complications
Time Frame: Immediately after the procedure, and 4 weeks/6 months/12 months post-procedure.
Rate of complications, including pain, burns, recurrent laryngeal nerve palsy, hematoma, nodule rupture, and deviation from euthyroidism
Secondary Outcomes
- Effectiveness(4 weeks/6 months/12 months post-procedure.)
- Quality of life(7-9 months post-procedure.)
Investigators
Jesse Pasternak
Principal Investigator
University Health Network, Toronto