- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00185081
Imaging Colo-rectal Cancer Using a Two Step Antibody Technique in Nuclear Imaging
Radioimmunodetection of CEA-Producing Tumors Using a Bispecific Antibody Pre-targeting Method and an In-Labeled Peptide
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6500 HB
- Radboud University Medical Centre Nijmegen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
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
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Wim Oyen, MD PhD, Radboud University Medical Centre Nijmegen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRISCO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colonic Neoplasms
-
Imperial College LondonCompletedColonic Diseases | Colonic Polyp | Colonic Neoplasms | Colonic Cancer | Colonic Adenocarcinoma | Colonic Adenoma | Colonic Carcinoma | Colonic Dysplasia | Colon Hyperplastic PolypUnited Kingdom
-
Hospital Universitario de MóstolesCompletedColonic Polyp | Colonic Neoplasms | Colonic Cancer
-
Changi General HospitalNational University Hospital, Singapore; Singapore General Hospital; Tan Tock...CompletedColonic Polyp | Colonic Neoplasms | Colonic DysplasiaSingapore
-
Institute of Gastroenterology and Advance EndoscopyNot yet recruitingColonic Polyp | Colonic Neoplasms | Colonic Adenoma | Colonic DiseaseArgentina
-
The University of Hong KongRecruitingColonic Polyp | Colonic Cancer | Colonic AdenomaHong Kong
-
Oxford University Hospitals NHS TrustCompletedRectal Cancer | Ulcerative Colitis | Colonic Cancer | Colonic DiverticulumUnited Kingdom
-
University of Turin, ItalyNot yet recruitingColonic Polyp | Colonic Neoplasms | Colonic Dysplasia
-
The University of Hong KongUnknownColonic Polyps | Colonic CancersHong Kong
-
UNC Lineberger Comprehensive Cancer CenterPfizer; AmgenActive, not recruitingColon Cancer | Colonic Cancer | Cancer of the Colon | Colon Neoplasms | Neoplasms, ColonicUnited States
-
Chinese University of Hong KongCompleted
Clinical Trials on Indium labeled IMP-205xm734
-
Mayo ClinicNational Cancer Institute (NCI)CompletedLymphoma | Small Intestine CancerUnited States
-
Centre René GauducheauCompletedSmall Cell Lung Cancer | CEA-expressing Non Small Cell Lung Carcinoma (NSCLC)France
-
Radboud University Medical CenterCompletedColorectal NeoplasmsNetherlands
-
Radboud University Medical CenterRecruiting
-
Nantes University HospitalInstitut National de la Santé Et de la Recherche Médicale, France; Gilead SciencesCompletedMedullary Thyroid CarcinomaFrance
-
Nantes University HospitalInstitut National de la Santé Et de la Recherche Médicale, France; Gilead SciencesCompletedHER2 Negative Breast Carcinoma Expressing CEAFrance
-
National Cancer Institute (NCI)CompletedRecurrent Adult Burkitt Lymphoma | Recurrent Adult Diffuse Large Cell Lymphoma | Waldenström Macroglobulinemia | Post-transplant Lymphoproliferative Disorder | Stage III Adult Burkitt Lymphoma | Stage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Burkitt Lymphoma | Stage IV Adult Diffuse...United States
-
National Cancer Institute (NCI)TerminatedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Grade 3 Follicular Lymphoma | Recurrent Marginal Zone Lymphoma | Splenic Marginal Zone... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedPost-transplant Lymphoproliferative Disorder | Recurrent Childhood Large Cell Lymphoma | Recurrent Childhood Lymphoblastic Lymphoma | Recurrent Childhood Small Noncleaved Cell Lymphoma | Recurrent/Refractory Childhood Hodgkin Lymphoma | AIDS-related Peripheral/Systemic Lymphoma | AIDS-related...United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedLymphoma | Leukemia | Graft Versus Host DiseaseUnited States