Status:
UNKNOWN
GLP-1 Receptor Expression in CHI
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
European Commission
University College, London
Conditions:
Congenital Hyperinsulinism
Eligibility:
All Genders
Up to 16 years
Brief Summary
The primary objective is the in vivo and ex vivo investigation of the expression and distribution of the GLP-1R in the pancreas of CHI patients.
Detailed Description
Congenital hyperinsulinism (CHI) is a rare disease of infants characterized by the presence of functionally defective non-neoplastic beta-cells with inappropriate (over-) secretion of insulin, leading...
Eligibility Criteria
Inclusion
- Biochemically and clinically proven endogenous congenital hyperinsulinism:
- Unresponsive to medical treatment (diazoxide)
- Indication for 18F-DOPA PET/CT based on mutation analysis
- Standard imaging (18F-DOPA PET/CT) not older than 8 weeks
- \<16 years old
- Informed consent signed by parents or legal guardians of the patient.
Exclusion
- Genetically proven diffuse CHI (presenting with a homozygous or compound heterozygous ABCC8/KCNJ11 mutation)
- Calculated creatinine clearance below 40 ml/min
- Evidence of other malignancy than insulin producing tumors in conventional imaging (suspicious liver, bone and lung lesions based on CT)
- Age \> 16 years
- No signed informed consent
Key Trial Info
Start Date :
February 7 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03768518
Start Date
February 7 2018
End Date
February 1 2019
Last Update
December 7 2018
Active Locations (1)
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1
Radboudumc
Nijmegen, Netherlands, 6500HB