ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer (iTEP Colon)

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: TF2 antibody/68Ga-IMP-288

Study type: Interventional

Funder types: Other

Identifiers

NCT02587247

RC14_0428

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

TF2 antibody/68Ga-IMP-288

Experimental group

Description:

TF2 antibody/68Ga-IMP-288

Treatment:

Drug: TF2 antibody/68Ga-IMP-288