Overview

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