18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
Recruiting
Phase 2
Interventional Study
Congenital Hyperinsulinism
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 0 Days – 18
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 50 (estimated)
- Sponsor
- Miguel Pampaloni · Other
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About This Trial
The goal of this project is to determine the role of FDOPA/PET as a pre-operative diagnostic imaging procedure for differentiating focal and diffuse forms of congenital hyperinsulinism and locating focal lesions in the pancreas to guide surgical resection.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Any age, but primarily infants 0-6 months given typical age of initial presentation.
* Children with diagnosis of FoHI or DiHI based on clinical criteria (fasting hypoglycemia accompanied by inadequate suppression of plasma insulin, inappropriately low plasma free fatty acid a…
Contacts
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