ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer

Launched by NANTES UNIVERSITY HOSPITAL · Oct 23, 2015

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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