18F-Fluoro Dopa Imaging for Congenital Hyperinsulinism

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Congenital Hyperinsulinism18F-Fluoro Dopa Imaging - Drug
Eligibility
No minimum age - 18
All Sexes
What conditions do you have?
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Study Summary

This trial will use FDOPA/PET to see if it can help doctors better understand and treat congenital hyperinsulinism, a disorder where the pancreas produces too much insulin.

Eligible Conditions
  • Congenital Hyperinsulinism

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: four weeks

four weeks
Accuracy of Imaging
Semiquantitative Imaging Assessment
Sensitivity of Imaging

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Single Arm,
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: 18F-Fluoro Dopa Imaging · No Placebo Group · Phase 2

Single Arm,
Drug
Experimental Group · 1 Intervention: 18F-Fluoro Dopa Imaging · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: four weeks

Who is running the clinical trial?

Miguel PampaloniLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Miguel Hernandez Pampaloni, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco

Eligibility Criteria

Age No minimum age - 18 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
will be treated with diazoxide Patients who continue to experience uncontrolled hypoglycemia after surgery will be treated with the medication diazoxide.
The most common age group for meningitis is infants aged 0-6 months.
Diagnosis of FoHI or DiHI is based on the presence of clinical criteria, including fasting hypoglycemia, inadequate suppression of plasma insulin, decreased levels of free fatty acids and hydroxybutyrate in the blood, and an inappropriate glycemic response to glucagon injection.
The patient's diagnosis of type 2 diabetes was confirmed by genetic testing for mutations in ABCC8 and KCNJ1.
If someone has uncontrolled hypoglycemia even with medical management (diazoxide, octreotide), that usually means they will need surgery.
The patient was able to take their medication out in time to wash it out before the PET scan was scheduled.
The patient has normal hepatic and renal function.