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Fluorodopa F 18 for Congenital Hyperinsulinism
Study Summary
This trial is investigating whether a new drug can help find and remove the part of the pancreas causing low blood sugars and brain damage in newborn babies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 2 trial • 43 Patients • NCT03778294Trial Design
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Who is running the clinical trial?
Media Library
- I am allergic to Fluorodopa F 18.My condition is linked to a genetic cause.My genetic tests for HI disease are either negative or not done, but I want surgery for a potential cure.My doctor recommends surgery for my severe hypoglycemia because medications haven't worked.I am being treated for hyperinsulinism at Cook Children's by an endocrinologist.I do not have a diagnosis of hyperinsulinism (HI).
- Group 1: Pancreatic Imaging with Fluorodopa F 18
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants are partaking in this investigation?
"Affirmative. Information on clinicaltrials.gov points to the trial's recruitment status - this experiment, which was initially posted in October of 2013 and last updated in January 2020 is actively seeking out 250 participants at a single site."
Are there any openings for individuals to join the research endeavor?
"Data hosted on clinicaltrials.gov demonstrates that this research is still recruiting participants, with the trial's initial posting date being October 9th 2013 and its most recent amendment having been January 29th 2020."
Has Fluorodopa F 18 achieved clearance from the FDA?
"Our team at Power has assigned Fluorodopa F 18 a score of 1 due to only preliminary data concerning its safety and efficacy, which is expected from Phase 1 trials."
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