Imaging Colo-rectal Cancer Using a Two Step Antibody Technique in Nuclear Imaging

Study Overview
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Brief Summary
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The purpose of this study is to test the safety of the peptide and antibody and at the same time evaluate the tumor imaging of a two step antibody technique in nuclear imaging.

Detailed Description
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Colo-rectal cancer has an incidence of 8000 cases per year in The Netherlands. Eventually 50% of them will die as a consequence of this disease. Treatment consists of resection of the primary tumor, followed by adjuvant chemotherapy in some patients. The chemotherapeutical agents, however, are only moderately effective with regard to increase of survival. New treatment modalities are therefore desirable. Radioimmunotherapy using radioactive labelled antibodies have proven to be effective in hematologic malignancies. Due to slow absorption in solid tumors however an effective radiation dose is not yet achieved. The aim of our study is to bypass this slow tumor uptake by the use of pre-targeting. We therefore use an unlabeled bispecific antibody infusion. This will be followed several days later by the infusion of a radiolabeled peptide that binds to the bispecific antibody. We hypothesise that this small peptide will be readily absorbed by the tumor which is pre-saturated by the bispecific antibody. As a consequence a higher radiation dose can be given with a lower toxicity.

Official Title
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Radioimmunodetection of CEA-Producing Tumors Using a Bispecific Antibody Pre-targeting Method and an In-Labeled Peptide

Conditions
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Colonic Neoplasms

Intervention / Treatment
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* Drug: Indium labeled IMP-205xm734


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years of age Histologic or cytologic diagnosis of colorectal cancer Karnofsky performance status >70% Exclusion Criteria: Pregnant or lactating women Severe anorexia Active second primary malignancy Chemotherapy or radiotherapy within four weeks of study entry

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indium labeled IMP-205xm734|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation of intravenous injection of In-labeled IMP-205 and hMN-14xm734 |  |  | 
| Tumor targeting of In-IMP-205 in patients with colorectal carcinoma |  |  | 
| Pharmacokinetics, biodistribution and dosimetry of In-IMP-205 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, radioimmunoscintigraphy, colon-specific antigen,, radioimmunotherapy,, radioimmunodetection