A Phase 2 interventional study of 18F-Fluoro Dopa Imaging in Congenital Hyperinsulinism, sponsored by Miguel Pampaloni. Recruiting at 1 site in United States. Open to participants aged 0 Days to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Miguel Pampaloni · Phase 2, Interventional, and Diagnostic
The goal of this project is to determine the role of FDOPA/PET as a pre-operative diagnostic imaging procedure for differentiating focal and diffuse forms of congenital hyperinsulinism and locating focal lesions in the pancreas to guide surgical resection.
Congenital hyperinsulinism (HI) is the most common cause of recurrent and persistent hypoglycemia, presenting early in infancy. Patients who fail medical therapy usually require resection of the diseased pancreas(partial or subtotal pancreatectomy) to control this disorder. Over half of patients undergoing surgery have a focal area of islet cell dysfunction that is curable with resection. These focal lesions are areas of adenomatosis consisting of a clone of beta-cells that express a paternally-derived mutation of the KATP channel due to loss of heterozygosity for the maternal allele. Current imaging techniques cannot differentiate focal and diffuse forms of hyperinsulinism, nor can they locate focal areas of disease within the pancreas before surgery. L-DOPA is taken up by some neuroendocrine cells, including pancreatic islet cells, and stored as dopamine in secretory granules. Recent studies show that positron emission tomography (PET) following administration of 18F-fluoro-L-DOPA (FDOPA) can distinguish focal and diffuse forms of HI and accurately locate focal lesions within the pancreas.
38 studies on the registry are indexed under Congenital Hyperinsulinism; 6 are open to participants now.
This study's planned enrollment of 50 is above the median of 17 across 30 interventional studies indexed under Congenital Hyperinsulinism.
Browse Congenital Hyperinsulinism studies →Miguel Pampaloni is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Children with diagnosis of FoHI or DiHI based on clinical criteria (fasting hypoglycemia accompanied by inadequate suppression of plasma insulin, inappropriately low plasma free fatty acid and plasma-hydroxybutyrate concentrations, and an inappropriate glycemic response to glucagon injection)
o confirmed by genetic testing for mutations in ABCC8 and KCNJ1 was1.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with clinically diagnosed congenital hyperinsulinism
Drug: 18F-Fluoro Dopa Imaging
Imaging with 18F-Fluoro Dopa PET Imaging
Sensitivity of Imaging
To determine the sensitivity and specificity of FDOPA PET/CT in differentiating focal and diffuse forms of HI in infants with medically refractory hypoglycemia
Time frame: four weeks
Accuracy of Imaging
To determine the accuracy of FDOPA PET/CT localizing areas of islet cell adenomatosis within the pancreas in patients with focal HI, by identifying the area of abnormal uptake of the raioligand
Time frame: four weeks
Semiquantitative Imaging Assessment
o determine whether data from FDOPA PET/CT can accurately quantify pancreatic islet cell mass in patients with HI (normal pancreas, areas of adenomatosis in focal HI and diseased pancreas in diffuse HI) by quantifying the standardized uptake value (SUV) of FDOPA of and correlating with histologic findings.
Time frame: four weeks
Plan to share: No
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Miguel Pampaloni