Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Adv… (NCT01403324) | Clinical Trial Compass
TerminatedNot Applicable
Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer
Stopped: Recruitment difficulties
France4 participantsStarted 2011-09
Plain-language summary
Metastases of thyroid cancer with iodine uptake are treated with repeated activity of I-131 administered after thyroid hormone withdrawal. The goal of thyroid hormone withdrawal is to treat patients with elevated thyrotropin stimulated hormone (TSH), a hormone secreted by the pituitary, a gland just located under the brain. Another way to obtain elevated TSH levels is to perform intramuscular injection of recombinant human TSH, a hormone produced pharmaceutically. The goal of this study is to know whether the radioiodine uptake by the metastases is similar after rhTSH administration or after thyroid hormone withdrawal.
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
. Patients with thyroid cancer and known measurable (\>1cm) distant metastases demonstrating radioiodine uptake on a previous whole body scan
. Patients planned for a therapeutic activity of 131I after thyroid hormone withdrawal
. Age \>18 years
. Previous treatment with radioiodine more than 6 months before inclusion.
. Serum TSH level \<0.5 mU/L
. Normal renal function with a creatinine clearance estimation using the Cockcroft-Gault formula \> 60 ml/ml
. Effective means of contraception for female patient, at risk of pregnancy
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.
. Patients whose majority of tumoral lesions disclose FDG uptake without radioactive iodine uptake
. Iodine excess (\< 50 μg/dl)
. Large or diffuse bone or brain metastases
. Patients with multiple small tumor foci less than 1 cm in diameter, such as miliary spread to the lungs
. Patients already included in a therapeutic trial with an experimental medicine
. Pregnancy and breast feeding patients
. Subject with any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures