Comparison of Dosimetry Following Preparation With Either rhTSH or After Withdrawal of Thyroid Hormone Suppression Therapy in Patients With Metastatic or Locally Advanced Differentiated Thyroid Cancer
Patients will undergo a rhTSH stimulation, staying on thyroid hormone treatment. Following 2
administration of rhTSH an injection of I-124 will be performed. Positron emission
tomography with computed tomography scans (PET/CT), blood tests, and measurements of whole
body radioactivity will occurred during the 4 to 96 hours following I-124 administration in
order to perform dosimetry (i.e.) to estimate the radiation dose delivered to the
metastases. After 4 weeks under thyroid hormones patients will undergo thyroid hormone
withdrawal and a new administration of I-124 will be performed. The same dosimetry study
will be realized with PET/CT, blood tests, and measurements of whole body radioactivity. A
therapeutic activity of I-131will then be administered followed by whole body scan realized
24 to 72 hours after the administration of I-131. Dosimetry studies will be compared in
order to determine whether rhTSH stimulation can replace thyroid hormone withdrawal for the
treatment of distant metastases.
Interventional
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
the 124 I uptake after TSH stimulation
For each patient, the 124 I uptake after TSH stimulation (a marker of radiation absorbed dose) will be compared to the uptake after thyroid withdrawal in all lesions (up to 16 lesions per patient maximum). A decrease in the residence time of more than 2.5 fold in 25% or more of the lesions is considered unacceptable.
4 to 96 hours
No
Sophie LEBOULLEUX, MD
Principal Investigator
Gustave Roussy, Cancer Campus, Grand Paris
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
DOSIMETA IGR2010/1645
NCT01403324
September 2011
September 2014
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