Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00185081
Status:
COMPLETED
Last Update Posted:
2016-04-07
First Post:
2005-09-15
Brief Title:
Imaging Colo-rectal Cancer Using a Two Step Antibody Technique in Nuclear Imaging
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Radioimmunodetection of CEA-Producing Tumors Using a Bispecific Antibody Pre-targeting Method and an In-Labeled Peptide
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None