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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
The patient's Endocrinologist has determined that the patient cannot be safely managed with standard medical therapy (failed) and surgery is recommended to prevent future episodes of severe hypoglycemia and preserve brain function. Failure of medical therapy is defined as hypoglycemia (blood glucose <70 m/dL) on a single measure despite the use of anti-hypoglycemic medications, if applicable to the individual patient, including and limited to diazoxide or octreotide, and inability to fast for specific durations based on age
Patients in whom the genetic testing (if available and informative) does not prove diffuse HI disease. Such children might be considered if they have no genetic testing results (e.g., due to insurance denial or parental refusal), negative genetic testing (note: only 75% of mutations may be found with existing technology), no autosomal recessive mutations in ABCC8 or KCNJ11 on the maternal allele, no autosomal dominant mutations in ABCC8 or KCNJ11, or patients thought to have focal HI disease based on genetic testing or insulinoma based on clinical evaluation and have well-controlled blood glucose levels with any degree of dietary or medical management, BUT the patient and their parent(s) or LAR wishes to proceed with surgery for a possible cure of HI disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one month
Awards & highlights

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.

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.Check my eligibility
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.See study design
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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My doctor recommends surgery for my severe hypoglycemia because medications haven't worked.
Select...
My genetic tests for HI disease are either negative or not done, but I want surgery for a potential cure.
Select...
I am being treated for hyperinsulinism at Cook Children's by an endocrinologist.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy of PET imaging compared to intraoperative pancreatic biopsy in patients with congenital hyperinsulinism
Radioactivity of 18F-DOPA following transport
Secondary outcome measures
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%
Encephalopathy
28%
Lymphocyte count decreased
23%
Platelet count decreased
21%
Weight loss
21%
Anorexia
10%
Blurred vision
10%
Dysphasia
8%
Memory impairment
5%
Pain
5%
Muscle weakness left-sided
3%
Dyspnea
3%
Muscle weakness right-sided
3%
Ataxia
3%
Abdominal pain
3%
Amnesia
3%
Irritability
3%
Concentration impairment
3%
Bruising
3%
Hypertension
3%
Agitation
3%
Adrenal insufficiency
3%
Muscle weakness lower limb
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (18F-DOPA, PET/MRI, PET/CT, Temozolomide)

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
6 Previous Clinical Trials
5,000,354 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
~66 spots leftby Jan 2028