Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-26 @ 8:22 PM
Study NCT ID:
NCT06929650
Status:
RECRUITING
Last Update Posted:
2025-04-16
First Post:
2025-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Feasibility of Radiofrequency Ablation to Treat Low-risk Thyroid Cancer
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Thermo-Ablation With Radiofrequency Medical Technologies to Treat Thyroid Cancers
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
• 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: