ImmunoTEP for Patients With Medullary Thyroid Carcinoma. (iTEP-CMT)
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|ClinicalTrials.gov Identifier: NCT01730638|
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : March 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Medullary Thyroid Carcinoma||Drug: • TF2 and 68 Ga-IMP-288||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|