ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Apport de l'Immuno-TEP préciblée Avec l'Anticorps bispécifique Anti-ACE x Anti-HSG TF2 et le Peptide IMP-288 marqué au Gallium-68 Pour l'Imagerie Des Patients Potentiellement Candidats à Une Chirurgie d'exérèse et/ou Thermoablation Locale d'Une ou Plusieurs métastases, au Diagnostic ou Lors de la Rechute de Cancers Colo-rectaux (CCR) Exprimant l'antigène Carcino-embryonnaire (ACE): Comparaison au Bilan Conventionnel

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: TF2 antibody/68Ga-IMP-288


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Existence of one or more metastases of of colorectal cancer (CRC) expressing the CEA , potentially accessible by surgical or thermo resection at the moment of the diagnosis or at relapse. OR Isolated and progressive elevation of plasma CEA during the monitoring of CRC with high metastatic risk More than 18 years Negative pregnancy test for women of childbearing age. Women of childbearing age should take effective continuous contraception for 3 months. At least 4 weeks after the last treatment and after recovery of potential toxicity Karnofsky more than 70 or ECOG 0-1 Life expectancy of at least 6 months CEA positive immunohistochemistry or plasma CEA supperior or equal to the normal level Creatinin less or equal 200 micromol/L Signed informed consent geographical proximity Exclusion Criteria: Pregnancy or breastfeeding Serious illness or comorbidity assessed risk History of other cancer within 5 years, with the exception of skin carcinomas other than melanomas or in-situ carcinoma of the cervix Anti-antibody presence in patients who have already received antibody Hypersensitivity to antibodies or proteins Intellectual inability to sign the informed consent Insulin-dependent diabetic patient or non-insulin dependent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TF2 antibody/68Ga-IMP-288<br>TF2 antibody/68Ga-IMP-288 | Drug: TF2 antibody/68Ga-IMP-288<br>* TF2 antibody coupled with 68Ga-IMP-288<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |