Imaging Colo-rectal Cancer Using a Two Step Antibody Technique in Nuclear Imaging
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00185081 |
Recruitment Status
:
Completed
First Posted
: September 16, 2005
Last Update Posted
: April 7, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colonic Neoplasms | Drug: Indium labeled IMP-205xm734 | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Radioimmunodetection of CEA-Producing Tumors Using a Bispecific Antibody Pre-targeting Method and an In-Labeled Peptide |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185081
Netherlands | |
Radboud University Medical Centre Nijmegen | |
Nijmegen, Gelderland, Netherlands, 6500 HB |
Study Director: | Wim Oyen, MD PhD | Radboud University Medical Centre Nijmegen |
Responsible Party: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00185081 History of Changes |
Other Study ID Numbers: |
PRISCO |
First Posted: | September 16, 2005 Key Record Dates |
Last Update Posted: | April 7, 2016 |
Last Verified: | April 2016 |
Keywords provided by Radboud University:
colon cancer radioimmunoscintigraphy colon-specific antigen, radioimmunotherapy, radioimmunodetection |
Additional relevant MeSH terms:
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Antibodies Immunologic Factors Physiological Effects of Drugs |