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 range18 Years
SexALL
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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
✓. Written informed consent
Exclusion criteria
✕. Patients whose majority of tumoral lesions disclose FDG uptake without radioactive iodine uptake
✕. 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