18FDOPA PET/MRI for Hyperinsulinism
(18FDOPA HI Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Washington University School of Medicine
Disqualifiers: Major illness, MRI contraindication, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
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.
What data supports the effectiveness of the treatment 18F-FDOPA PET/MRI Imaging for hyperinsulinism?
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.678910
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.1231112
Eligibility Criteria
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.
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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.
Trial Timeline
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
Treatment Details
Interventions
- 18F-Fluoro Dopa PET/MRI Imaging (Radiopharmaceutical)
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 18F-Fluoro Dopa ImagingExperimental Treatment1 Intervention
single arm
18F-Fluoro Dopa PET/MRI Imaging is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as 18F-Fluorodopa PET for:
- Evaluation of adult patients with suspected Parkinsonian syndromes
- Detection and localization of focal lesions in the pancreas causing hyperinsulinism
🇪🇺 Approved in European Union as 18F-DOPA PET for:
- Detection of neuroendocrine tumors
- Staging and restaging of carcinoid tumors
- Detection of persistent and residual medullary thyroid cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington UniversitySaint Louis, MO
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Who Is Running the Clinical Trial?
Washington University School of MedicineLead Sponsor
St. Louis Children's HospitalCollaborator
References
18F-FDOPA: a multiple-target molecule. [2016]Although 6-(18)F-fluoro-L-dopa ((18)F-FDOPA) has been available to study the striatal dopaminergic system for more than 2 decades, the full potential of the tracer was not realized before the introduction of (18)F-FDOPA PET and PET/CT to image a variety of neuroendocrine tumors (NETs) and pancreatic beta-cell hyperplasia. Together with receptor-based imaging, (18)F-FDOPA offers a formerly unforeseen means to assist in the management of NETs and infants with persistent hyperinsulinemic hyperplasia. Institutions with special expertise in surgical, oncologic, and radiologic therapeutic modalities for NETs derive the highest benefit from (18)F-FDOPA PET/CT. (18)F-FDOPA-guided therapy may add to NET control by ensuring maximal cytoreduction.
Limited value of 18F-F-DOPA PET to localize pancreatic insulin-secreting tumors in adults with hyperinsulinemic hypoglycemia. [2019]Fluorine-18-L-dihydroxyphenylalanine positron emission tomography (18F-FDOPA PET) imaging is increasingly used in the workup of neuroendocrine tumors. It has been shown to be an accurate tool in the diagnosis of congenital hyperinsulinism, but limited information is available on its value in adult disease. OBJECTIVE, PATIENTS, AND DESIGN: The objective of this study was to review our experience with 18F-FDOPA PET imaging in six consecutive patients with hyperinsulinemic hypoglycemia (HH) (four solitary insulinomas, one diffuse beta-cell hyperplasia, one malignant insulinoma). 18F-FDOPA uptake was also evaluated in 37 patients (43 procedures) without HH or other pancreatic neuroendocrine tumors, which acted as a control group.
Diagnostic accuracy of [¹⁸F]-fluoro-L-dihydroxyphenylalanine positron emission tomography scan for persistent congenital hyperinsulinism in Japan. [2022]We aimed to elucidate the accuracy and limitations of [(18)F]-fluoro-L-dihydroxyphenylalanine ([(18) F]DOPA) positron emission tomography (PET) for Japanese patients with congenital hyperinsulinism. Although [(18)F]DOPA PET is reported to be useful for precisely localizing the focal form of congenital hyperinsulinism, previous reports are mostly from European and North American centres.
Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) positron emission tomography as a tool to localize an insulinoma or beta-cell hyperplasia in adult patients. [2022]Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) positron emission tomography (PET) is a promising method in localizing neuroendocrine tumors. Recently, it has been shown to differentiate focal forms of congenital hyperinsulinism of infancy. The current study was set up to determine the potential of 18F-DOPA PET in identifying the insulin-secreting tumors or beta-cell hyperplasia of the pancreas in adults.
Early 18F-FDOPA PET/CT imaging after carbidopa premedication as a valuable diagnostic option in patients with insulinoma. [2020]Label="PURPOSE">Data on the diagnostic value of 18F-FDOPA PET/CT in patients with insulinoma are limited and are focused on small patient populations explored using different PET/CT protocols and the inconsistent use of carbidopa premedication. The aim of this study was to improve the current knowledge about the diagnostic value of 18F-FDOPA PET/CT combined with oral carbidopa premedication and early pancreatic imaging for tumour localization in patients with insulinoma-related hyperinsulinaemic hypoglycaemia (HH). The relationships among 18F-FDOPA quantitative uptake parameters, insulin secretion and tumour pathological features were also investigated.
Molecular MRI of the Cardiovascular System in the Post-NSF Era. [2021]Two new molecular MRI agents have been approved for clinical use within the last 3 years, and a third agent has completed phase-2 clinical trials. A wealth of preclinical data is also emerging on the general safety of many molecular MR imaging agents. In addition, since the guidelines to avoid nephrogenic systemic fibrosis (NSF) were adopted, at most institutions no new cases of NSF have been reported. Nevertheless, in the post-NSF environment, both those developing and using molecular MR imaging agents need to be increasingly aware of safety issues. This awareness should begin with the design of the agent and, even in early preclinical studies, the demonstration of safety and efficacy should both be given high priority. In this review we discuss some of the issues relevant to the design of safe molecular MR imaging agents and highlight the excellent safety profile of those agents that have been used clinically to date.
Safety issues related to intravenous contrast agent use in magnetic resonance imaging. [2021]Gadolinium-based contrast agents (GBCAs) have been used to improve image quality of MRI examinations for decades and have an excellent overall safety record. However, there are well-documented risks associated with GBCAs and our understanding and management of these risks continue to evolve. The purpose of this review is to discuss the safety of GBCAs used in MRI in adult and pediatric populations. We focus particular attention on acute adverse reactions, nephrogenic systemic fibrosis and gadolinium deposition. We also discuss the non-GBCA MRI contrast agent ferumoxytol, which is increasing in use and has its own risk profile. Finally, we identify special populations at higher risk of harm from GBCA administration.
Safety profile of ultrasmall superparamagnetic iron oxide ferumoxtran-10: phase II clinical trial data. [2019]The safety data from the phase II clinical trial of ferumoxtran-10, an ultrasmall superparamagnetic iron oxide contrast agent, are presented. One hundred and four patients with focal liver or spleen pathologies underwent ferumoxtran-10-enhanced magnetic resonance (MR) imaging at doses of 0.8, 1.1, and 1.7 mg Fe/kg. Overall, 15% patients reported a total of 33 adverse events, regardless of causality. The adverse events most frequently seen were dyspnea (3.8%), chest pain (2.9%), and rash (2.9%). No serious adverse events were reported during the 48 hour observation period. There were no clinically significant effects on vital signs, physical examination, and laboratory results. Ferumoxtran-10 is a safe and well tolerated MR contrast agent.
[Clinical evaluation of the tolerability of gadodiamide, a new nonionic contrast agent in MRI of the central nervous system]. [2014]Gadodiamide injection (Gd-DTPA-BMA) is a new non-ionic paramagnetic contrast agent for which the safety at the dose 0.1 mmol/kg was evaluated during a European multicentre study on a large population of adult patients who had an MR examination of the central nervous system with contrast medium. The safety analysis was performed on 2,102 patients by recording the adverse events observed during injection and up to 24 hours after the injection. Adverse events due or probably due to gadodiamide injection were observed in 102 patients (4.4%) with injection-site associated discomfort (heat, coldness, pain at the injection site) in 37 patients (1.8%) and adverse events other than discomfort (headache, nausea, vomiting) in 35 patients (3.1%). No adverse events of severe intensity or death were reported during the trial. Gadodiamide injection was shown to be safe and well tolerated and represents a non-ionic alternative to the current products in the field of MR imaging of the central nervous system.
Adverse Effects of Gadolinium-Based Contrast Agents: Changes in Practice Patterns. [2022]Gadolinium-based contrast agents have been used for magnetic resonance imaging (MRI) examinations since the late 1980s with an excellent overall cumulative safety record. Initially favored for use in patients with renal impairment because of lack of significant nephrotoxic effect at clinical doses, in 2006, multiple reports convincingly linked the rare but serious disease nephrogenic systemic fibrosis to the administration of gadolinium-based contrast agents in patients with severe renal failure. This in turn led to new policies on administration of these agents, resulting in changes in practice patterns that have virtually resulted in the elimination of the disease after the year 2009. The purpose of this review is to summarize the factors that led to the emergence of nephrogenic systemic fibrosis, including the risk associated with different types of contrast agents based on their stability, and the changes in practice patterns and usage of gadolinium-based contrast agents in recent years that have been mainly driven by the discovery and association with nephrogenic systemic fibrosis. The article will conclude with a brief overview of new emerging safety concerns that could further impact the use of this class of contrast agents and impact practice patterns in the future.
Lasting 18F-DOPA PET uptake after clinical remission of the focal form of congenital hyperinsulinism. [2017]Positron emission tomography (PET) using (18)F-DOPA is a useful tool for detecting the focal forms of congenital hyperinsulinism. (18)F-DOPA is taken up by aromatic L-amino acid decarboxylase in pancreatic β-cells. However, the role of this enzyme in insulin secretion is unknown.
Fluorine-18 DOPA-PET and PET/CT Imaging in Congenital Hyperinsulinism. [2016]Congenital hyperinsulinism is the principle cause of hypoglycemia during infancy but successful treatment is difficult and persistent hypoglycemia carries the risk of neurologic damage. Focal and diffuse abnormalities are the common forms of hyperinsulinism. Identification and localization of focal hyperinsulinism can be cured by partial pancreatectomy. It has been shown that affected pancreatic areas utilize LDOPA in a higher rate than normal pancreatic tissue and, thus, labeling L-DOPA with fluorine-18 (FDOPA) allows functional mapping of hyperinsulinism using PET. This article presents a fundamental overview of the genetics background, pathology, management, and the role of FDOPA-PET imaging in hyperinsulinism.