The Safety and Feasibility of Radiofrequency Ablation to Treat Low-risk Thyroid Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity Health Network, Toronto
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Nodule less than or equal to 2cm in size
Their age is ≥18 years and ≤100 years
Able to provide written consent
Able to attend required follow-ups as per the protocol
Disqualifiers
Patients <18 years old
Pregnant women
Any concern for invasive or metastatic thyroid cancer
Previously treated for thyroid cancer
Trial design
Design model
Single group
Treatments tested in this trial
Radiofrequency ablation
Procedure/SurgeryRadiofrequency 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).
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complications
Rate of complications, including pain, burns, recurrent laryngeal nerve palsy, hematoma, nodule rupture, and deviation from euthyroidism
Time frame
Immediately after the procedure, and 4 weeks/6 months/12 months post-procedure.Secondary outcomes
1
Effectiveness
Volume reduction rate of thyroid nodule (%)
Time frame
4 weeks/6 months/12 months post-procedure.2
Effectiveness
Description of overall symptoms
Time frame
4 weeks/6 months/12 months post-procedure.3
Effectiveness
Cosmesis score reduction (scale 0-10 where 0 indicates no issues with cosmesis)
Time frame
4 weeks/6 months/12 months post-procedure.4
Quality of life
The Body Image Scale is a patient-reported questionnaire used to assess how cancer or its treatment affects a person's perception of their body. It asks about feelings related to appearance, self-consciousness, and changes in how the person views their body after receiving RFA. Responses are given on a 4-point scale: "Not at all," "A little," "Quite a bit," and "Very much." Higher scores generally indicate greater body image concerns or distress.
Time frame
7-9 months post-procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov