ClinicalTrials.gov record NCT04205604

18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

18F-Fluoro-L- DOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.

AgeUnder 1 month old to 18 years old

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 2 diagnostic imaging study tests 18F‑fluoro-L‑DOPA (FDOPA) PET/CT to distinguish focal from diffuse congenital hyperinsulinism and to locate focal pancreatic lesions before surgery. It is aimed at infants and children (up to 18 years) with congenital hyperinsulinism, typically when hypoglycemia is not controlled by medical treatment. Participants receive an FDOPA PET/CT scan and imaging results are compared with clinical, surgical, and histologic findings when available.

What it is studying. The study is testing whether FDOPA PET/CT scans can tell apart focal versus diffuse forms of congenital hyperinsulinism and accurately locate focal areas of abnormal islet cells in the pancreas prior to surgery.

What the researchers hope to learn. To determine the sensitivity and specificity of FDOPA PET/CT for differentiating focal and diffuse congenital hyperinsulinism; to assess how accurately the scan localizes focal islet-cell lesions in the pancreas; and to evaluate whether FDOPA uptake measurements correlate with histologic measures of islet cell involvement.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: 18F-Fluoro Dopa Imaging

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

Any age, but primarily infants 0-6 months given typical age of initial presentation.
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.
Hypoglycemia uncontrolled with medical management (diazoxide, octreotide).
Able to withdraw medications in time to wash out prior to the scheduled PET scan.
Patients fulfilling criteria above but with uncontrolled hypoglycemia after initial surgical management (partial or near-total pancreatectomy)
Normal hepatic and renal function.

Exclusion criteria

Treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon).
Patients with hepatic or renal insufficiency.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will receive an 18F‑fluoro‑L‑DOPA PET/CT imaging study (an injection of the tracer followed by PET/CT scanning). They may need blood tests to confirm liver and kidney function and must be able to stop certain medications beforehand to allow a washout period. If participants later have pancreatic surgery, the PET/CT results may be compared with surgical or tissue (histologic) findings. The record does not provide further details about visit number or other study procedures.

How the study is structured. An interventional, single-group, open (no masking) Phase 2 diagnostic study. Participants receive an 18F‑fluoro-L‑DOPA (FDOPA) PET/CT imaging procedure; the scans are compared with clinical and surgical/histology findings where available to assess test performance.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on congenital hyperinsulinism

Clinical trials5 trials listed for congenital hyperinsulinismEvery trial the registry lists for congenital hyperinsulinism, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in congenital hyperinsulinism researchLatest monthly update: September 2026. Includes: After-surgery medicines. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Nov 3, 2016
Primary completion: Dec 1, 2026 (estimated)
Study completion: Dec 1, 2026 (estimated)
Target enrollment: 50 participants (estimated)
Last updated on registry: May 1, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Miguel Pampaloni

Participating sites (1)

University of California, San FranciscoRecruiting
San Francisco, California, 94143 · United States
- Miguel Hernandez Pampaloni, MD, PhD · 415-353-1886

Terms used on this page · explanations by MedicalUpdates.ai

PET: A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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