NCT05088798

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
44mo left

Started Sep 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Sep 2020Jan 2030

Study Start

First participant enrolled

September 10, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

9.3 years

First QC Date

June 18, 2021

Last Update Submit

December 17, 2025

Conditions

Hyperinsulinism

Keywords

hypoglycemiaGlucose Metabolism DisordersInfant, Newborn, DiseasesHyperinsulinismInsulinoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Secondary Outcomes (1)

  • Accuracy of 18FDOPA PET/MRI to identify focal forms of hyperinsulinism that may be cured by surgery

    one year

Study Arms (1)

18F-Fluoro Dopa Imaging

EXPERIMENTAL

single arm

Drug: 18F-Fluoro Dopa PET/MRI Imaging

Interventions

18F-Fluoro Dopa PET/MRI ImagingDRUG

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
18F-Fluoro Dopa Imaging

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with confirmed hyperinsulinemic hypoglycemia, diagnosed by elevated insulin levels during hypoglycemia and/or response to glucagon stimulation.
  • Subjects who failed pharmacological therapy with diazoxide or octreotide.
  • Subjects with signed informed consent by themselves or their parents or legal guardians.
  • 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.

You may not qualify if:

  • 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.
  • Cases in which surgery will not be considered by parents or guardians.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

HyperinsulinismHypoglycemiaGlucose Metabolism DisordersInfant, Newborn, DiseasesInsulinoma

Interventions

fluorodopa F 18

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAdenoma, Islet CellAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Ana Maria Arbelaez, MD, MSCI

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela S Stone, RN

CONTACT

314-747-4659stone.p@wustl.edu

Ana Maria Arbelaez, MD, MSCI

CONTACT

314-286-1138aarbelaez@wustl.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2021

First Posted

October 22, 2021

Study Start

September 10, 2020

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

We will share de-identified data with researchers at other institutions in a HIPPA compliant format.

Shared Documents
CSR
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.

Locations

US(1)