Status:
COMPLETED
Phase II Safety and Efficacy Study of 18FDOPA PET-CT in Children With Hyperinsulinemic Hypoglycemia
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
University of Pennsylvania
Conditions:
Congenital Hyperinsulinism (CHI)
Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery to remove part or all of their pancreas. In this study, researchers will test how we...
Detailed Description
For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas ...
Eligibility Criteria
Inclusion
- Infants and children with a clinical diagnosis of hyperinsulinism who are suspected to have focal disease and are surgical candidates for pancreatectomy
Exclusion
- Pregnant or lactating females
- Any other major illness or condition that might substantially increase the risk associated with the subject's participation in this study.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01468454
Start Date
January 1 2009
End Date
February 1 2018
Last Update
October 13 2022
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104