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New scan could pinpoint hidden pancreas problems, avoiding major surgery

NCT ID NCT05088798

Diagnosis Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a special PET/MRI scan using 18F-DOPA can accurately locate small, overactive areas in the pancreas that cause too much insulin (hyperinsulinism). The goal is to help doctors decide if surgery can remove just the problem spot, potentially curing the condition. The study involves 100 people whose hyperinsulinism has not improved with medication and who are being considered for surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
18F-DOPA (a radioactive tracer used in PET imaging)
What this could lead to
If successful, this imaging test could help doctors precisely locate the overactive pancreas tissue, allowing for targeted surgery that may cure hyperinsulinism without removing the whole pancreas.
What could go wrong
This is a Phase 2 study with only 100 participants, so results may not apply to everyone. The test's accuracy is still being compared to standard surgical findings, and it may not work for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with confirmed hyperinsulinemic hypoglycemia, diagnosed by elevated insulin levels during hypoglycemia and/or response to glucagon stimulation. 2. Subjects who failed pharmacological therapy with diazoxide or octreotide. 3. Subjects with signed informed consent by themselves or their parents or legal guardians. 4. Patient's Endocrinologist has determined that the patient cannot be safely managed with standard medical therapy (failed) and surgery is recommended to prevent future episodes of severe hypoglycemia and preserve brain function. Exclusion Criteria: 1. 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. 2. Patient must not have any contraindication to MRI as evaluated by a standardized MRI safety questionnaire. If MRI is contraindicated, and patient meets inclusion criteria and has no other contraindications study will be conducted in PET/CT scanner. 3. Cases in which surgery will not be considered by parents or guardians.

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Conditions

The condition(s) this trial relates to.

familial hyperinsulinism glucose metabolism disease hyperinsulinism hypoglycemia Infant, Newborn, Diseases pancreatic insulinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperinsulinism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

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