ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer (NCT02587247) | Clinical Trial Compass
CompletedPhase 2
ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer
France11 participantsStarted 2016-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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