Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses (NCT00615537) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses
United States20 participantsStarted 2008-02
Plain-language summary
This proposal is designed as a pilot study for the use of laser ablation for local control of symptomatic (e.g compressive) benign thyroid masses in 20 patients.
Who can participate
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:
* Histologically or cytologically documented benign thyroid nodule, or cold thyroid nodule as documented by thyroid scan.
* Patient has been evaluated by endocrinology and endocrine surgery and has been deemed suitable candidate for procedure.
* The patient's nodule(s) size and number must be no larger than 5cm and a maximum of 3 nodules, respectively.
* All nodules must be greater than 1cm from the expected location of the recurrent laryngeal and vagus nerves determined under ultrasound.
* Required initial laboratory values: T3, T4. TSH, and Thyroglobulin (for treated metastatic lymph nodes)
* All patients must understand and sign a study-specific informed consent.
Exclusion Criteria:
* Thyroid mass in contact with trachea or esophagus.
* Uncontrolled coagulopathy or bleeding diathesis that cannot be corrected with FFP and platelets prior to procedure. (Platelets must be ≥ 70,000/ul.)
* Aspirin and nonsteroidal anti-inflammatory medications, antiplatelet medications, or warfarin must be discontinued prior to the procedure for a time period that is appropriate given the drug half-life and the drugs known antiplatelet activity (e.g. aspirin for 7 days and ibuprofen 24 hours). Low molecular weight heparin preparations must be discontinued 24 hours prior to procedure.
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
The primary goal of this study is to determine the local response of laser ablation of the treated lesion and its effect on size and vascularity. The objective measures will be based on serial US with Doppler.