adult hyperinsulinemic hypoglycemia
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Biochemically proven endogenous hyperinsulinemic hypoglycemia: neuroglycopenic symptoms in the fasting state with low plasma glucose, inappropriately high serum insulin and C-peptide concentrations • Signed informed consent • Standard imaging not older than 8 weeks. This includes a triple-phase CT or MRI, somatostatin receptor imaging (68Ga-DOTATOC, 68Ga-DOTATATE or 111In-DTPA-octreotide SPECT/CT) and endocopic ultrasound (EUS).
Exclusion criteria
Exclusion criteria: • Breast feeding • Pregnancy or the wish to become pregnant within 6 months • Calculated creatinine clearance below 40ml/min • Evidence of other malignancy than insulin producing tumors in conventional imaging (suspicious liver, bone and lung lesions) • Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of sensitivity, specificity, positive predictive value, diagnostic odds ratio and receiver operating characteristics between 68Ga-NODAGA-exendin 4 PET/CT and conventional imaging such as triple phase CT, MRI, F-18-DOPA, C-11-HTP and 68Ga-DOTATOC/DOTATATE PET/CT in adult patients with biochemically proven endogenous hyperinsulinemic hypoglycemia in the fasting state. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Calculation of the organ- and effective dose of 68Ga-NODAGA-exendin 4 • Assessing the impact on clinical management of GLP-1R imaging • Calculation and comparison of the interobserver variability of 68Ga-NODAGA-exendin 4 PET/CT and EUS combined with triple phase CT or MRI • Comparison of imaging parameters (SUVmax), intraoperative findings, histology and GLP-1/sst2 receptor expression in vitro autoradiography on frozen tissue samples | — |
Countries
Netherlands
Outcome results
None listed