100 Participants Needed

18FDOPA PET/MRI for Hyperinsulinism

(18FDOPA HI Trial)

KJ
Overseen ByKathleen J Wharton, BSN, RN
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is to provide access to 18F-DOPA PET to patients at Washington University and assess the utility of 18F-DOPA PET/MRI as a preoperative tool to detect and localize focal lesions in the pancreas that are causing hyperinsulinism.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems likely that you may continue your medications unless advised otherwise by your doctor.

Is 18FDOPA PET/MRI safe for humans?

The safety of 18FDOPA PET/MRI specifically isn't detailed in the provided articles, but MRI contrast agents generally have a good safety record. Gadolinium-based agents, commonly used in MRI, have been linked to a rare condition in patients with severe kidney issues, but new guidelines have minimized this risk.12345

How is the 18F-FDOPA PET/MRI treatment different from other treatments for hyperinsulinism?

The 18F-FDOPA PET/MRI treatment is unique because it uses a special imaging technique to detect areas of the pancreas with abnormal insulin production, which can help in precisely locating and treating focal forms of hyperinsulinism. This approach is particularly useful for identifying specific areas that may require surgical intervention, unlike other treatments that may not provide such detailed localization.678910

What data supports the effectiveness of the treatment 18F-FDOPA PET/MRI Imaging for hyperinsulinism?

Research shows that 18F-FDOPA PET is useful in diagnosing congenital hyperinsulinism by accurately locating the problem areas in the pancreas, especially in infants. It has also been used to help manage neuroendocrine tumors, which are similar to the conditions being studied in this trial.6791112

Who Is on the Research Team?

AM

Ana Maria Arbelaez

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subjects with signed informed consent by themselves or their parents or legal guardians
I have been diagnosed with low blood sugar due to high insulin levels.
I have tried diazoxide or octreotide for my condition without success.
See 1 more

Exclusion Criteria

Any other major illness or condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in this study
Surgery is not an option for me as decided by my parents or guardians.
I can safely undergo an MRI, or if not, a PET/CT scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo 18F-DOPA PET/MRI imaging to detect and localize focal lesions in the pancreas

1-2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and potential surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • 18F-Fluoro Dopa PET/MRI Imaging
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: 18F-Fluoro Dopa ImagingExperimental Treatment1 Intervention

18F-Fluoro Dopa PET/MRI Imaging is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as 18F-Fluorodopa PET for:
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as 18F-DOPA PET for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

St. Louis Children's Hospital

Collaborator

Trials
30
Recruited
83,200+

Published Research Related to This Trial

The introduction of 6-(18)F-fluoro-L-dopa ((18)F-FDOPA) PET and PET/CT imaging has enhanced the ability to study neuroendocrine tumors (NETs) and pancreatic beta-cell hyperplasia, providing a valuable tool for diagnosis and management.
Institutions with expertise in treating NETs can significantly benefit from (18)F-FDOPA PET/CT, as it aids in guiding therapy to achieve better tumor control and maximize cytoreduction.
18F-FDOPA: a multiple-target molecule.Minn, H., Kauhanen, S., Seppรคnen, M., et al.[2016]
In a study involving six patients with hyperinsulinemic hypoglycemia, 18F-FDOPA PET imaging was only positive in one case, indicating its limited effectiveness in detecting insulinomas and beta-cell hyperplasia in adults.
The pancreatic uptake of 18F-FDOPA was not significantly different between patients with hyperinsulinemic hypoglycemia and a control group, suggesting that this imaging technique may not reliably localize insulin-secreting tumors in adults.
Limited value of 18F-F-DOPA PET to localize pancreatic insulin-secreting tumors in adults with hyperinsulinemic hypoglycemia.Tessonnier, L., Sebag, F., Ghander, C., et al.[2019]
In a study of 17 Japanese infants with congenital hyperinsulinism, [(18)F]DOPA PET showed limited accuracy in diagnosing the condition, with only 7 out of 17 cases aligning with molecular diagnoses when assessed by simple inspection.
The diagnostic accuracy improved significantly when using a quantitative measure called the 'Pancreas Percentage', leading to consistent results in 10 out of 17 patients, indicating that this method enhances the effectiveness of [(18)F]DOPA PET for this population.
Diagnostic accuracy of [ยนโธF]-fluoro-L-dihydroxyphenylalanine positron emission tomography scan for persistent congenital hyperinsulinism in Japan.Masue, M., Nishibori, H., Fukuyama, S., et al.[2022]

Citations

18F-FDOPA: a multiple-target molecule. [2016]
Limited value of 18F-F-DOPA PET to localize pancreatic insulin-secreting tumors in adults with hyperinsulinemic hypoglycemia. [2019]
Diagnostic accuracy of [ยนโธF]-fluoro-L-dihydroxyphenylalanine positron emission tomography scan for persistent congenital hyperinsulinism in Japan. [2022]
Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) positron emission tomography as a tool to localize an insulinoma or beta-cell hyperplasia in adult patients. [2022]
Early 18F-FDOPA PET/CT imaging after carbidopa premedication as a valuable diagnostic option in patients with insulinoma. [2020]
Molecular MRI of the Cardiovascular System in the Post-NSF Era. [2021]
Safety issues related to intravenous contrast agent use in magnetic resonance imaging. [2021]
Safety profile of ultrasmall superparamagnetic iron oxide ferumoxtran-10: phase II clinical trial data. [2019]
[Clinical evaluation of the tolerability of gadodiamide, a new nonionic contrast agent in MRI of the central nervous system]. [2014]
10.United Statespubmed.ncbi.nlm.nih.gov
Adverse Effects of Gadolinium-Based Contrast Agents: Changes in Practice Patterns. [2022]
Lasting 18F-DOPA PET uptake after clinical remission of the focal form of congenital hyperinsulinism. [2017]
12.United Statespubmed.ncbi.nlm.nih.gov
Fluorine-18 DOPA-PET and PET/CT Imaging in Congenital Hyperinsulinism. [2016]
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