ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TF2 antibody/68Ga-IMP-288

Group Type EXPERIMENTAL

TF2 antibody/68Ga-IMP-288

Intervention Type DRUG

TF2 antibody coupled with 68Ga-IMP-288

Interventions

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TF2 antibody/68Ga-IMP-288

TF2 antibody coupled with 68Ga-IMP-288

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No