Your session is about to expire
← Back to Search
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
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to one month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one month
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 • NCT0377829492%
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%
Dysphasia
10%
Blurred vision
8%
Memory impairment
5%
Pain
5%
Muscle weakness left-sided
3%
Ataxia
3%
Agitation
3%
Hypertension
3%
Concentration impairment
3%
Amnesia
3%
Adrenal insufficiency
3%
Abdominal pain
3%
Irritability
3%
Dyspnea
3%
Bruising
3%
Muscle weakness right-sided
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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).
Research Study Groups:
This trial has the following groups:- Group 1: Pancreatic Imaging with Fluorodopa F 18
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
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
Popular Categories
Share this study with friends
Copy Link
Messenger