ImmunoTEP for Patients With Medullary Thyroid Carcinoma. (iTEP-CMT)
|Medullary Thyroid Carcinoma||Drug: • TF2 and 68 Ga-IMP-288||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||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.|
- Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288 [ Time Frame: one week ]
Decrease of TF2 and IMP- 288 molar doses and variation of pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 120 to 30 nmol of TF2 and 6 à 1.5 nmol of peptides 1 to 3 days apart.
A last cohort (number 5 or 6) with optimal conditions will be proposed 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.
- Sensibilité [ Time Frame: 6 monts after immunoTEP ]
- tolerance [ Time Frame: 6 monts after immunoTEP ]
- a second _iTEP if necessary for the follow up of a lesion [ Time Frame: 6 monts after immunoTEP ]with in the follow up of the pateint
|Study Start Date:||January 2013|
|Study Completion Date:||December 2016|
|Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Drug: • TF2 and 68 Ga-IMP-288
- • TF2: trivalent recombinant humanized antibody recognizing the ACE and the peptide histamine-succinyl-glycine IMP-288 (HSG)
- • 68 Ga-IMP-288: di-HSG peptide-DOTA-labeled with Gallium 68
Variation of TF2 molar dose, IMP-288 molar dose and pretargeting interval will be performed in 4 to 5 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.
A last cohort (cohorte number 5 or 6) with optimal conditions will be proposed. Whole-body PET images will be recorded 60 and 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.
some patient will have a second immuno-TEP for their follow up in the first examen was the most sensible.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730638
|Angers, France, 49100|
|Nantes, France, 44100|
|Institut de Cancérologie de l'ouest, René Gauducheau|
|Sant Herblain, France, 44805|
|Principal Investigator:||Francoise Bodere, PhD, MD||Nantes Hospital|