Paraganglioma
Conditions
Interventions
Trade Name: Byetta
Product Name: 68Ga-NODAGA-exendin-4
Pharmaceutical Form: Radiopharmaceutical precursor, solution
Sponsors
Radboud University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Proven PGL with a single tumor detected using standard diagnostic imaging • No evidence of metastatic disease • SSTR PET performed • Scheduled for surgery • Able to sign informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main study aim of the study is to examine the feasibility of detecting PGLs using 68Ga-exendin-4 PET/CT. ;Secondary Objective: The secondary objectives are: •Determining the optical timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT. •Comparing quantitative imaging parameters (SUV, tumor-to-background ratio, contract-to-noise ratio) between 68Ga-exendin-4 PET/CT and SSTR PET/CT. •Assessing the correlation between GLP-1R expression and tracer uptake in the PGLs. •Correlating quantitative imaging results and IHC data to the genetic origin of the PGLs. •Assessing safety / side effects of 68Ga-exendin-4 in patients with PGL ;Primary end point(s): Detection rate of PGLs using 68Ga-exendin-4 PET/CT;Timepoint(s) of evaluation of this end point: At the end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Optimal timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT. • Comparison of quantitative imaging parameters (SUV, tumor-to-background ratio, contract-to-noise ratio) between 68Ga-exendin-4 PET, 18F-FDG PET and SSTR PET. • Correlation between GLP-1R expression and tracer uptake in the PGLs. • Correlation quantitative imaging results and IHC data to the genetic origin of the PGLs. ;Timepoint(s) of evaluation of this end point: First endpoint after inclusion of 3 participants, the rest at the end of the trial | — |
Countries
Netherlands
Contacts
Public ContactDepartement of Nuclear Medicine
Radboud University Medical Center
Outcome results
None listed