Ignite Creation Date:
2024-05-06 @ 5:44 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05418907
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2022-06-02
Brief Title:
Exendin PETCT for Imaging of Paragangliomas
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Exendin PETCT for Paragangliomas
Status:
RECRUITING
Status Verified Date:
2023-11
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:
ENTRAP
Brief Summary:
Functional imaging of paragangliomas PGLs is not unequivocal Existing functional imaging modalities show good but variable results in PGLs warranting the search for additional molecular imaging targets Investigators aim to evaluate the glucagon-like peptide 1 receptor GLP-1R as a novel target for molecular imaging of PGLs For this purpose investigators will use the tracer 68Ga-NODAGA-exendin 4 for positron emission tomographycomputed tomography PETCT imaging
Detailed Description:
Rationale
Functional imaging of paragangliomas PGLs is not unequivocal Existing functional imaging modalities show good but variable results in PGLs warranting the search for additional molecular imaging targets Investigators aim to evaluate the glucagon-like peptide 1 receptor GLP-1R as a novel target for molecular imaging of PGLs For this purpose investigators will use the tracer 68Ga-NODAGA-exendin 4 for positron emission tomographycomputed tomography PETCT imaging
Objective
The primary objective is to examine the feasibility of 68Ga-exendin-4 PETCT for localization and functional characterization of PGLs
Study design
In this prospective pilot imaging study 68Ga-exendin-4 PETCT will be performed in 10 patients with confirmed PGL who have undergone CT somatostatin receptor SSTR PETCT and 18F-FDG PETCT as standard diagnostic procedures and are scheduled for surgery 100 10 MBq 68Ga-NODAGA-exendin-4 will be administered to 10 patients in total In the first 5 patients PETCT imaging will be performed 1 2 and 4 hours after injection to determine the optimal imaging timepoint for the remainder of the patients which will be applied in the remaining patients
The images will be reconstructed and evaluated by a nuclear medicine physician who is blinded to the results of the CT SSTR PETCT and 18F-FDG PETCT to assess tumor detection Additionally quantitative analysis of 68Ga-exendin-4 SSTR PET and 18F-FDG PETCT images will be performed After the patients have undergone surgery immunohistochemical analysis of surgical specimens will be performed to assess GLP-1R expression which will be compared with in vivo tracer uptake
Functional imaging of paragangliomas PGLs is not unequivocal Existing functional imaging modalities show good but variable results in PGLs warranting the search for additional molecular imaging targets Investigators aim to evaluate the glucagon-like peptide 1 receptor GLP-1R as a novel target for molecular imaging of PGLs For this purpose investigators will use the tracer 68Ga-NODAGA-exendin 4 for positron emission tomographycomputed tomography PETCT imaging
Objective
The primary objective is to examine the feasibility of 68Ga-exendin-4 PETCT for localization and functional characterization of PGLs
Study design
In this prospective pilot imaging study 68Ga-exendin-4 PETCT will be performed in 10 patients with confirmed PGL who have undergone CT somatostatin receptor SSTR PETCT and 18F-FDG PETCT as standard diagnostic procedures and are scheduled for surgery 100 10 MBq 68Ga-NODAGA-exendin-4 will be administered to 10 patients in total In the first 5 patients PETCT imaging will be performed 1 2 and 4 hours after injection to determine the optimal imaging timepoint for the remainder of the patients which will be applied in the remaining patients
The images will be reconstructed and evaluated by a nuclear medicine physician who is blinded to the results of the CT SSTR PETCT and 18F-FDG PETCT to assess tumor detection Additionally quantitative analysis of 68Ga-exendin-4 SSTR PET and 18F-FDG PETCT images will be performed After the patients have undergone surgery immunohistochemical analysis of surgical specimens will be performed to assess GLP-1R expression which will be compared with in vivo tracer uptake
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None