imaging of insulin producing cells in patients with genetic insulin overproductio

Phase 1

• Conditions: Congenital hyperinsulinism; MedDRA version: 20.0Level: PTClassification code 10061211Term: HyperinsulinismSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2016-002279-88-NL
• Lead Sponsor: European Commission

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-27
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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 PETICT) not older than 8 weeks
- < 16 years old
- informed consent signed by parents or legal guardians of the patient.
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Genetically proven diffuse CHI (presenting with a homozygous or compound heterozygous ABCCS/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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified