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NCT04205604 · ClinicalTrials.gov registry record · Phase 2
18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
A Phase 2 study of Congenital Hyperinsulinism, sponsored by Miguel Pampaloni.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04205604: Recruiting Phase 2 study of Congenital Hyperinsulinism, sponsored by Miguel Pampaloni.
NCT04205604 is a Phase 2 study of Congenital Hyperinsulinism that is actively recruiting participants, run by Miguel Pampaloni. The registered enrollment target is 50 participants, below the 71-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (30% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04205604, a Phase 2 study of Congenital Hyperinsulinism, is actively recruiting participants, sponsored by Miguel Pampaloni.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
To determine the sensitivity and specificity of FDOPA PET/CT in differentiating focal and diffuse forms of HI in infants with medically refractory hypoglycemia
Conditions Studied
Interventions
- DRUG 18F-Fluoro Dopa Imaging
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-11-03 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What NCT04205604 shows while recruiting
NCT04205604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 71-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Congenital Hyperinsulinism appearing as the primary indexed condition, and to 1 intervention - of which 18F-Fluoro Dopa Imaging is the first listed.
NCT04205604 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04205604 about?
NCT04205604 is a clinical study titled "18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism". 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.
What is the current status of trial NCT04205604?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2016-11-03. Estimated completion is 2025-12-31.
What conditions does trial NCT04205604 study?
This clinical trial studies the following conditions: Congenital Hyperinsulinism.
What interventions are being tested in trial NCT04205604?
The interventions under investigation include: 18F-Fluoro Dopa Imaging (DRUG).
Who is sponsoring clinical trial NCT04205604?
This trial is sponsored by Miguel Pampaloni, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04205604 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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