Cryoablation of Benign Thyroid Nodules: a Pilot Study (NCT06014229) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cryoablation of Benign Thyroid Nodules: a Pilot Study
Brazil10 participantsStarted 2023-08-24
Plain-language summary
This study will evaluate the clinical response and safety of ultrasound guided percutaneous cryoablation in the treatment of benign thyroid nodules as an alternative to the surgery. Ablation of functioning or non-functioning benign thyroid nodules with cryoablation will be directed to patients with symptomatic benign thyroid lesions (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component; patients must present with serum free thyroxine (T4) and thyroid stimulating hormone (TSH) between the normal range values, with no signs of thyroiditis by serum antibodies over 100% of the standard values; calcitonin levels in the normal range values. Cryoablation will be directed to patients in a non-randomized fashion. Clinical, laboratorial and imaging monitoring will be performed in 12 months, including contrast-enhanced ultrasound when indicated, by 1, 3, 6 and 12 months.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years of age or older
* Patients with solitary or dominant functioning or non-functioning thyroid nodules with two consecutive fine needle aspiration biopsy (FNAb)-proven benign in the last 12 months
* Thyroid nodules should be solid or almost solid (less than 40% of liquid component) with volume between 5 and 65 cc;
* Patients considered high surgical risk candidates or patients are eligible to surgery who are informed about the ablation therapy and prefers it instead surgery;
* Calcitonin, thyroglobulin or TSH serum levels in the normal range values
Exclusion Criteria:
* Age under 18 years
* Extensive goiter
* Predominantly cystic nodule with small solid remnant (less than 10%)
* Nodule volume \> 65 cc
* TSH levels above the normal range
* Uncorrectable coagulopathy / impossibility to interrupt anticoagulants;
* Malignant or suspected malignant cytologic specimens;
* Pregnancy or breast-feeding;
* Anaplastic or poor-differentiated thyroid carcinoma;
* Partial thyroidectomy
* Asymptomatic patients
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
evaluation of technical feasibility
Timeframe: immediately after ablation
2
2) Incidence of adverse events secondary to the treatment (safety and tolerability) of thermal ablation of benign thyroid nodules