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Radiopharmaceutical
18FDOPA PET/MRI for Hyperinsulinism (18FDOPA HI Trial)
Phase 2
Recruiting
Led By Ana Maria Arbelaez, MD, MSCI
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with confirmed hyperinsulinemic hypoglycemia, diagnosed by elevated insulin levels during hypoglycemia and/or response to glucagon stimulation
Subjects who failed pharmacological therapy with diazoxide or octreotide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
18FDOPA HI Trial Summary
This trial will provide access to 18F-DOPA PET to patients with suspected focal lesions in the pancreas. The goal is to use 18F-DOPA PET/MRI to detect and localize these lesions, which will help guide surgery.
Who is the study for?
This trial is for patients with hyperinsulinemic hypoglycemia who can't be managed safely with standard treatments and need surgery. They must have high insulin levels during low blood sugar episodes or respond to glucagon stimulation, have failed therapy with diazoxide or octreotide, and provide informed consent.Check my eligibility
What is being tested?
The study tests the use of a special imaging technique called 18F-Fluoro Dopa PET/MRI to find and pinpoint focal lesions in the pancreas causing hyperinsulinism before surgery at Washington University.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include reactions related to the PET/MRI contrast agent used (like mild allergic reactions), discomfort from lying still during imaging, and exposure to radiation typical of such scans.
18FDOPA HI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with low blood sugar due to high insulin levels.
Select...
I have tried diazoxide or octreotide for my condition without success.
Select...
My doctor recommends surgery because standard treatments for my low blood sugar haven't worked.
18FDOPA HI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Increase Access to 18F-DOPA PET/MRI (or PET/CT) for patients with HI who failed medical therapy
Secondary outcome measures
Accuracy of 18FDOPA PET/MRI to identify focal forms of hyperinsulinism that may be cured by surgery
18FDOPA HI Trial Design
1Treatment groups
Experimental Treatment
Group I: 18F-Fluoro Dopa ImagingExperimental Treatment1 Intervention
single arm
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,773 Total Patients Enrolled
St. Louis Children's HospitalOTHER
29 Previous Clinical Trials
93,446 Total Patients Enrolled
Ana Maria Arbelaez, MD, MSCIPrincipal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Surgery is not an option for me as decided by my parents or guardians.I have been diagnosed with low blood sugar due to high insulin levels.I can safely undergo an MRI, or if not, a PET/CT scan.I have tried diazoxide or octreotide for my condition without success.My doctor recommends surgery because standard treatments for my low blood sugar haven't worked.
Research Study Groups:
This trial has the following groups:- Group 1: 18F-Fluoro Dopa Imaging
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.
Are there any open slots available to participate in this trial?
"Currently, this medical trial is enlisting participants as per records kept by clinicaltrials.gov. The initial posting for the study was dated September 10th 2020, with a recent edit on October 8th 2021."
Answered by AI
What potential risks might patients be exposed to when undergoing 18F-Fluoro Dopa PET/MRI Imaging?
"After taking into account the Phase 2 status of this imaging technique, our team at Power assigned it a safety score of two due to some existing data that supports its security but no evidence backing up its efficacy."
Answered by AI
What is the scale of this experiment in terms of participants?
"Affirmative. According to the information available on clinicaltrials.gov, this medical investigation is currently seeking research subjects; with an initial post date of September 10th 2020 and a recent update on October 8th 2021. The trial aims to recruit 100 people from one site."
Answered by AI
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