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| Descriptive Information Fields | |||||||||
| Brief Title † | Imaging Colo-Rectal Cancer Using a Two Step Antibody Technique in Nuclear Imaging | ||||||||
| Official Title † | Radioimmunodetection of CEA-Producing Tumors Using a Bispecific Antibody Pre-Targeting Method and an In-Labeled Peptide | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics/Dynamics Study | ||||||||
| Primary Outcome Measure † | 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 |
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| Secondary Outcome Measure † | |||||||||
| Condition † | Colonic Neoplasms | ||||||||
| Intervention † | Drug: Indium labeled IMP-205xm734 | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 42 | ||||||||
| Start Date † | July 2005 | ||||||||
| Completion Date | December 2007 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | Netherlands | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00185081 | ||||||||
| Organization ID | PRISCO | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Radboud University | ||||||||
| Collaborators †† | Immunomedics, Inc. | ||||||||
| Investigators † |
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| Information Provided By | Radboud University | ||||||||
| Verification Date | February 2007 | ||||||||
| First Received Date † | September 15, 2005 | ||||||||
| Last Updated Date | February 28, 2007 | ||||||||
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