ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: Antibodies

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