STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection (NCT07612293) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection
United States100 participantsStarted 2026-09-02
Plain-language summary
This clinical trial studies how well thyroid lobectomy with ipsilateral central neck dissection works to treat medullary thyroid cancer (MTC) in patients without a germline RET mutation (sporadic). Currently, sporadic and germline RET (rearranged during transfection) mutation positive MTCs that are limited to the thyroid are managed in the same way, complete surgical removal of the entire thyroid gland (total thyroidectomy) with surgical removal of lymph nodes and other tissues on both sides of the neck (bilateral central neck dissection). Total thyroidectomy and bilateral central neck dissection carry a high risk of complications, and total thyroidectomy requires patients to take lifelong thyroid hormone replacement therapy, which can impact quality of life. Research has shown that patients with sporadic MTC do not have a high risk of developing MTC in the remaining normal thyroid tissue and that they may be able to be managed differently than patients with germline RET mutations. Thyroid lobectomy with ipsilateral central neck dissection is a surgical procedure which removes only the lobe of the thyroid gland that is affected by cancer as well as the lymph nodes and other tissues from the affected side of the neck. Thyroid lobectomy with ipsilateral central neck dissection may be a safer, more tolerable, and/or more effective way to treat sporadic MTC.
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:
* Male or female ≥ 18 years of age at time of diagnosis
* Documentation of a medullary thyroid cancer diagnosis as evidenced by:
* Thyroid fine needle aspiration biopsy with cytologist consistent with medullary thyroid cancer
* Indeterminate cytology from thyroid fine needle aspiration with elevated serum calcitonin OR thyroid molecular testing consistent with medullary thyroid cancer
* Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study
* Appropriate candidate for thyroid lobectomy and/or total thyroidectomy
Exclusion Criteria:
* Indication for total thyroidectomy unrelated to medullary thyroid cancer:
* Graves' disease
* Symptomatic multinodular goiter
* Contralateral symptomatic benign nodules
* Ultrasound findings consistent with:
* Cervical lymphadenopathy involving lateral neck or contralateral central neck
* Suspicious thyroid nodules \> 1 cm that are Thyroid Imaging Reporting and Data Systems 2 (TIRADS2) or higher without fine needle aspiration (FNA)
* Pure cystic and spongiform nodules do not require FNA
* Patients with nodules that meet criteria above can elect to undergo FNA, and may enroll in study if benign cytology is noted
* Identification of germline RET mutation on preoperative genetic testing
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
Proportion of patients who achieve biochemical remission
Timeframe: Up to 3 months
2
Proportion of patients requiring completion thyroidectomy