68Ga-NODAGA-exendin-4 PET/CT in patients with AHH - a prospective comparative evaluation of preoperative imaging

Phase 2

Completed

Conditions: adult hyperinsulinemic hypoglycemia
10018424
10014705

Registration Number: NL-OMON40821

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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

• 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 < 18 years
• No signed informed consent

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Comparison of sensitivity, specificity, positive predictive value, diagnostic<br /><br>odds ratio and receiver operating characteristics between 68Ga-NODAGA-exendin 4<br /><br>PET/CT and conventional imaging such as triple phase CT, MRI, F-18-DOPA,<br /><br>C-11-HTP and 68Ga-DOTATOC/DOTATATE PET/CT in adult patients with biochemically<br /><br>proven endogenous hyperinsulinemic hypoglycemia in the fasting state.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Calculation of the organ- and effective dose of 68Ga-NODAGA-exendin 4<br /><br>• Assessing the impact on clinical management of GLP-1R imaging<br /><br>• Calculation and comparison of the interobserver variability of<br /><br>68Ga-NODAGA-exendin 4 PET/CT and EUS combined with triple phase CT or MRI<br /><br>• Comparison of imaging parameters (SUVmax), intraoperative findings, histology<br /><br>and GLP-1/sst2 receptor expression in vitro autoradiography on frozen tissue<br /><br>samples </p><br>