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Evaluation of the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68 for imaging potential candidate patients for surgery of local resection of one or more metastases at diagnosis or during relapse CCR expressing CEA.
Injection of a bispecific anti-CEA x anti-HSG antibody TF2 (120 nmoles) and 30 hours later IMP-288 peptide labeled with gallium-68 (3 to 6 nmoles/150 MBq). A TEP imaging acquisition is plannified 60 min after the 68-Ga injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TF2 antibody/68Ga-IMP-288 | Experimental | TF2 antibody/68Ga-IMP-288 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TF2 antibody/68Ga-IMP-288 | Drug | TF2 antibody coupled with 68Ga-IMP-288 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68 | Initial and M3 imaging assessment comparaison, and/or immunohistochemistry | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the diagnostic performance of immuno-PET with morphological and functional imaging procedures currently performed in the imaging assessment (CT, ultrasound + liver MRI, FDG-PET). | Identified lesions at initial and M3 imaging assessment will be compared with lesions identified with 68-Ga-PET | Month 3 |
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Inclusion Criteria:
OR
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Nantes | 44093 | France | |||
| Institut de cancérologie de l'Ouest |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32820369 | Derived | Touchefeu Y, Bailly C, Frampas E, Eugene T, Rousseau C, Bourgeois M, Bossard C, Faivre-Chauvet A, Rauscher A, Masson D, David A, Cerato E, Carlier T, Sharkey RM, Goldenberg DM, Barbet J, Kraeber-Bodere F, Bodet-Milin C. Promising clinical performance of pretargeted immuno-PET with anti-CEA bispecific antibody and gallium-68-labelled IMP-288 peptide for imaging colorectal cancer metastases: a pilot study. Eur J Nucl Med Mol Imaging. 2021 Mar;48(3):874-882. doi: 10.1007/s00259-020-04989-3. Epub 2020 Aug 21. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| To Determine the value of immuno-PET in terms of specificity and predictive value. This determination will be made at the "patient" and at the "injury level. |
Comparaison with baseline imaging assessment, Month 3 imaging and/or immunohistochemistry evaluation |
| Month 3 |
| To assess the safety of the procedure | Biological and clinical examen of the patients between Day 1 and month 3 follow up. The assement will be according to NCI criteria | Month 3 |
| Search for the development of a blood Immunization against the products | Human anti Human antibody test by immuno assay at base line, M1 and M3 | Month 3 |
| To study the expression of CEA intensity on surgical excision parts in surgical patients and compare it to the semi-quantitative immuno-PET | Immunohistochemistry analysis with anti CEA antibody | No more than 3 months (it depend of the day of the surgery) |
| To evaluate the clinical impact (new lecture of imaging, new examens) | A form will be fill in by the physican who request the immuno PET | M1 |
| Saint-Herblain |
| 44805 |
| France |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |