RADIATION
68Ga-NODAGA-exendin-4 PET/CT
PET/CT imaging 1 hour after injection of 100 MB 68Ga-NODAGA-exendin-4
Status
Unknown
Phase
Not applicable
Enrollment
10
Locations
1
Results
Not posted
Publications
0
Study 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 tomography/computed tomography (PET/CT) imaging.
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 tomography/computed tomography (PET/CT) imaging. Objective: The primary objective is to examine the feasibility of 68Ga-exendin-4 PET/CT for localization and functional characterization of PGLs. Study design: In this prospective pilot imaging study 68Ga-exendin-4 PET/CT will be performed in 10 patients with confirmed PGL who have undergone CT, somatostatin receptor (SSTR) PET/CT and 18F-FDG PET/CT (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 PET/CT 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 PET/CT and 18F-FDG PET/CT to assess tumor detection. Additionally, quantitative analysis of 68Ga-exendin-4, SSTR PET and 18F-FDG PET/CT 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.
Interventions
RADIATION
PET/CT imaging 1 hour after injection of 100 MB 68Ga-NODAGA-exendin-4
Timeline
First posted
Jun 14, 2022
Study start
Jun 1, 2022
Primary completion
Dec 1, 2024
Study completion
Dec 1, 2024
Results posted
Not reported
Registry updated
Dec 8, 2023
Outcomes
detection rate of PGL's using 68Ga-exendin-4 PET/CT
Time frame · 1 year
Detection based on visual inspection of PET/CT images
optimal timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT
Time frame · After inclusion of the first 5 patients (up to 6 months)
Eligibility
Inclusion Criteria: * Proven sympathetic PGL with a single tumor detected using standard diagnostic imaging * No evidence of metastatic disease * CT, SSTR PET/CT and 18F-FDG PET/CT performed (golden standard diagnostic imaging) * Scheduled for surgery * Able to sign informed consent Exclusion Criteria: * Breast feeding * Pregnancy or the wish to become pregnant within 1 month * Calculated creatinine clearance below 40ml/min * Evidence of other malignancy than PGL in conventional imaging (suspicious liver, bone and lung lesions) * Age \< 18 years * Not able to sign informed consent
Study locations
Netherlands. Showing up to 24 locations stored in the fast local snapshot.
Radboud University Medical Center
Nijmegen, Netherlands
Publications
No PMID-linked publications were present in this registry snapshot.
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