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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
11
TF2 antibody coupled with 68Ga-IMP-288
CHU
Nantes, France
Institut de cancérologie de l'Ouest
Saint-Herblain, France
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
Time frame: Month 3
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
Time frame: Month 3
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: No more than 3 months (it depend of the day of the surgery)
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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
Time frame: M1