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Fluorodopa F 18 for Congenital Hyperinsulinism

Phase 1
Recruiting
Led By Paul Thornton, MD
Research Sponsored by Cook Children's Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Must not have
Patients with a known allergy to Fluorodopa F 18 agent
Patients with genetic evidence of diffuse HI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one month
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for patients with congenital hyperinsulinism (HI) or insulinoma, who are being treated at the Cook Children's Congenital Hyperinsulinism Center. It's suitable for those without genetic proof of diffuse HI, considering surgery to cure their condition. Pregnant women, those allergic to Fluorodopa F 18, without an HI diagnosis, and nursing mothers not pausing breastfeeding post-injection are excluded.
What is being tested?
The study tests if a new drug called Fluorodopa F 18 can help locate the exact area in the pancreas causing too much insulin when used with a PET scan. This could enable surgeons to remove just that part and potentially cure the patient.
What are the potential side effects?
While specific side effects of Fluorodopa F 18 aren't listed here, common ones may include reactions at injection site, nausea or headache. Allergic reactions might occur in rare cases.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am allergic to Fluorodopa F 18.
Select...
My condition is linked to a genetic cause.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one month
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Accuracy of PET imaging compared to intraoperative pancreatic biopsy in patients with congenital hyperinsulinism
Radioactivity of 18F-DOPA following transport
Secondary study objectives
Accuracy of PET imaging compared to intraoperative pancreatic biopsy in patients with insulinoma
Ratio of Standard Uptake Value max to sub max

Side effects data

From 2023 Phase 2 trial • 43 Patients • NCT03778294
92%
Fatigue
74%
Alopecia
62%
Central nervous system necrosis
54%
Headache
51%
Confusion
41%
Seizure
28%
Lymphocyte count decreased
28%
Encephalopathy
23%
Platelet count decreased
21%
Weight loss
21%
Anorexia
10%
Blurred vision
10%
Dysphasia
8%
Memory impairment
5%
Muscle weakness left-sided
5%
Pain
3%
Hypertension
3%
Amnesia
3%
Ataxia
3%
Adrenal insufficiency
3%
Muscle weakness right-sided
3%
Dyspnea
3%
Agitation
3%
Abdominal pain
3%
Bruising
3%
Muscle weakness lower limb
3%
Concentration impairment
3%
Irritability
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (18F-DOPA, PET/MRI, PET/CT, Temozolomide)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pancreatic Imaging with Fluorodopa F 18Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorodopa F 18
2019
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Cook Children's Health Care SystemLead Sponsor
9 Previous Clinical Trials
5,000,609 Total Patients Enrolled
Paul Thornton, MDPrincipal InvestigatorCook Children's Health Care System

Media Library

Fluorodopa F 18 Clinical Trial Eligibility Overview. Trial Name: NCT02021604 — Phase 1
Insulinoma Research Study Groups: Pancreatic Imaging with Fluorodopa F 18
Insulinoma Clinical Trial 2023: Fluorodopa F 18 Highlights & Side Effects. Trial Name: NCT02021604 — Phase 1
Fluorodopa F 18 2023 Treatment Timeline for Medical Study. Trial Name: NCT02021604 — Phase 1
~54 spots leftby Jan 2028
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