Metastatic Colorectal Cancer
Conditions
Brief summary
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
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.
Interventions
DRUGTF2 antibody/68Ga-IMP-288
TF2 antibody coupled with 68Ga-IMP-288
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Month 3 | Initial and M3 imaging assessment comparaison, and/or immunohistochemistry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Month 3 | Identified lesions at initial and M3 imaging assessment will be compared with lesions identified with 68-Ga-PET |
| 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. | Month 3 | Comparaison with baseline imaging assessment, Month 3 imaging and/or immunohistochemistry evaluation |
| To assess the safety of the procedure | Month 3 | Biological and clinical examen of the patients between Day 1 and month 3 follow up. The assement will be according to NCI criteria |
| Search for the development of a blood Immunization against the products | Month 3 | Human anti Human antibody test by immuno assay at base line, M1 and M3 |
| To study the expression of CEA intensity on surgical excision parts in surgical patients and compare it to the semi-quantitative immuno-PET | No more than 3 months (it depend of the day of the surgery) | Immunohistochemistry analysis with anti CEA antibody |
| To evaluate the clinical impact (new lecture of imaging, new examens) | M1 | A form will be fill in by the physican who request the immuno PET |
Countries
France
Outcome results
None listed