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New treatment option for Congenital Hyperinsulinism
Official title 18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
ClinicalTrials.gov ID: NCT04205604
What this study is testing
What is 18F-Fluoro Dopa Imaging?
18F-Fluoro Dopa Imaging is an investigational medicine, being studied as a potential treatment for congenital hyperinsulinism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 18
You may be able to join if
- 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...
- Hypoglycemia uncontrolled with medical management (diazoxide, octreotide).
- Able to withdraw medications in time to wash out prior to the scheduled PET scan.
- Patients fulfilling criteria above but with uncontrolled hypoglycemia after initial surgical management (partial or near-total pancreatectomy)
You likely can't join if
- Treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon).
- Patients with hepatic or renal insufficiency.
See the full eligibility 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 and plasma-hydroxybutyrate...
- Hypoglycemia uncontrolled with medical management (diazoxide, octreotide).
- Able to withdraw medications in time to wash out prior to the scheduled PET scan.
- Patients fulfilling criteria above but with uncontrolled hypoglycemia after initial surgical management (partial or near-total pancreatectomy)
- Normal hepatic and renal function.
- Treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon).
- Patients with hepatic or renal insufficiency.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 days to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.