Imaging Colo-rectal Cancer Using a Two Step Antibody Technique in Nuclear Imaging
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Radioimmunodetection of CEA-Producing Tumors Using a Bispecific Antibody Pre-targeting Method and an In-Labeled Peptide|
- 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
|Study Start Date:||July 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185081
|Radboud University Medical Centre Nijmegen|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Study Director:||Wim Oyen, MD PhD||Radboud University Medical Centre Nijmegen|