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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| Gilead Sciences | INDUSTRY |
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The aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TF2 antibody/68Ga-IMP-288 | Experimental | TF2 coupled with 68 Ga-IMP-288 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| • TF2 and 68 Ga-IMP-288 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. | one week |
| Measure | Description | Time Frame |
|---|---|---|
| Sensibilité | 6 monts after immunoTEP |
| Measure | Description | Time Frame |
|---|---|---|
| tolerance | 6 monts after immunoTEP | |
| a second _iTEP if necessary for the follow up of a lesion | with in the follow up of the pateint | 6 monts after immunoTEP |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francoise Bodere, PhD, MD | Nantes Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers Hospital | Angers | 49100 | France | |||
| Nantes Hospital |
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| ID | Term |
|---|---|
| D018276 | Carcinoma, Medullary |
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| Nantes |
| 44100 |
| France |
| Institut de Cancérologie de l'ouest, René Gauducheau | Saint-Herblain | 44805 | France |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |
| D004700 | Endocrine System Diseases |