Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT03768518
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
16 Years
Study:
NCT03768518
Study Brief:
Protocol Section:
NCT03768518