Pharmacokinetic and Imaging Optimization Study of Pretargeted Immuno-PET Using the Anti-CEA x Anti-HSG TF2 Bispecific Antibody and 68Ga-IMP-288 Peptide in Patients With Recurrences of Medullary Thyroid Carcinoma.
Variation of TF2 molar dose, IMP-288 molar dose and pretargeting interval will be performed
in 3 cohorts of 3 patients, receiving 30 to 120 nmol of TF2 and 1.5 to 6 nmol of peptides 1
to 3 days apart. Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections.
Whole-body PET images will be recorded 60 to 120 minutes after 68Ga-IMP-288 injection to
assess semi-quantitatively tumor targeting and tumor/background ratio. Moreover, the
targeting sensitivity of the TF2-pretargeted 68Ga-IMP-288 will be compared to standard
methods of tumor
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288
Decrease of TF2 and IMP- 288 molar doses and variation of pretargeting interval will be performed in 3 cohorts of 3 patients, receiving 120 to 30 nmol of TF2 and 6 à 1.5 nmol of peptides 1 to 3 days apart. Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections. Whole-body PET images will be recorded 60 to 120 minutes after 68Ga-IMP-288 injection to assess semiquantitatively tumor targeting and tumor/background ratio.
one week
No
Francoise Bodere, PhD, MD
Principal Investigator
Nantes Hospital
France : Agence National de Sécurité du Médicament (ANSM)
BRD 11/5-L
NCT01730638
October 2012
October 2014
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