A Phase 2 interventional study of 18F-Fluoro Dopa PET/MRI Imaging in Hyperinsulinism, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Diagnostic
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.
Congenital hyperinsulinism (CHI) is a clinically and genetically heterogeneous disorder that is the most common cause of permanent hypoglycemia in infants and children. More than 50% of the medically-unresponsive patients have focal disease. Which is characterized by a distinct region of Beta-cell hyperplasia in the pancreas, due to a somatic loss of a gene that regulates cell proliferation. Resection of the involved region cures most cases of focal HI. Therefore, preoperative identification and localization of focal HI lesions is useful for diagnostic confirmation and surgical guidance of patients with HI that fail pharmacological therapy and are being considered for surgery.
Insulinomas are benign insulin secreting neuroendocrine neoplasms located in the pancreas. They are the most common cause of endogenous hyperinsulinemic hypoglycemia in adults. Approximately 90% are solitary, benign and \< 2cm in diameter and therefore represent a challenge to localize. The small size of insulinomas makes detection by conventional imaging techniques such as contrast-enhanced CT (ceCT) and contrast-enhanced MRI challenging. As surgery appears to be the only available treatment option, it remains very critical to localize the tumor to facilitate pancreas preserving surgery. Endoscopic ultrasound is well established in the detection of insulinomas. However, this technique is operator dependent, invasive, and the visualization of the pancreas tail is not always possible. Therefore better imaging techniques to detect these lesions are needed for surgical planning.
Though not FDA approved, noninvasive imaging with 18F-fluoro-L-DOPA (FDOPA) is considered an integral part of standards of care management to identify focal lesions in CHI and potentially insulinomas. This is based on the fact that 18F-DOPA is selectively taken up by neuroendocrine cells, and thus, in focal HI, dense collections of endocrine cells can be visualized by an experienced radiologist. This study aims to determine if using combined positron emission tomography and magnetic resonance imaging will better localize the lesions and help the investigators determine which areas of the pancreas are affected, and assist with the surgical plan.
112 studies on the registry are indexed under Hyperinsulinism; 24 are open to participants now.
This study's planned enrollment of 100 is above the median of 29 across 79 interventional studies indexed under Hyperinsulinism.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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single arm
Drug: 18F-Fluoro Dopa PET/MRI Imaging
Drug page: Fluorodopa F 18
The purpose of this research study is to provide access to an imaging study of the pancreas that uses 6-\[18F\]-Fluoro-L-3,4,-dihydroxyphenylalanine (18F-DOPA)positron emission tomography (PET) and assess the accuracy of this 18F-DOPA-PET/MRI test on distinguishing what part of the pancreas is affected in patients with Hyperinsulinism.
Also known as: 6-[18F]-Fluoro-L-3,4,-dihydroxyphenylalanine, 18F-DOPA, [18F]-Fluorodopa
Increase Access to 18F-DOPA PET/MRI (or PET/CT) for patients with HI who failed medical therapy
To provide access to 18F-DOPA PET/MRI (or PET/CT) for patients with HI who do not respond to pharmacological therapy and are being considered for pancreatic surgery. We will measure this by totaling the number of scans performed yearly.
Time frame: one year
Accuracy of 18FDOPA PET/MRI to identify focal forms of hyperinsulinism that may be cured by surgery
To identify if data from 18FDOPA PET/MRI imaging can accurately diagnose focal forms of HI when compared to the gold-standard of histopathological findings obtained at surgery in subjects who received a partial or complete pancreatectomy. Currently this type of isotope is not available for diagnosis, of insulinomas.
Time frame: one year
Plan to share: Yes — We will share de-identified data with researchers at other institutions in a HIPPA compliant format.
Supporting information: Clinical study report
Time frame: Data will be available upon request.
Access criteria: PET Imaging data may be shared with other investigators in a HIPPA compliant manor for potential collaboration.
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Studies of the drug tested here: Fluorodopa F 18
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