Utility of 18FDOPA PET/MRI for Focal Hyperinsulinism

NCT ID: NCT05088798

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-10
• Study Completion Date: 2030-01-01

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.

Detailed Description

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.

Conditions

Hyperinsulinism

Keywords

hypoglycemia; Glucose Metabolism Disorders; Infant, Newborn, Diseases; Hyperinsulinism; Insulinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-Fluoro Dopa Imaging

single arm

Group Type: EXPERIMENTAL

18F-Fluoro Dopa PET/MRI Imaging

Intervention Type: DRUG

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.

Interventions

18F-Fluoro Dopa PET/MRI Imaging

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.

Intervention Type: DRUG

Other Intervention Names

6-[18F]-Fluoro-L-3,4,-dihydroxyphenylalanine; 18F-DOPA; [18F]-Fluorodopa

Eligibility Criteria

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.

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

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Louis Children's Hospital

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Maria Arbelaez, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pamela S Stone, RN

Role: CONTACT

Phone: 314-747-4659

Email: stone.p@wustl.edu

Ana Maria Arbelaez, MD, MSCI

Role: CONTACT

Phone: 314-286-1138

Email: aarbelaez@wustl.edu

Facility Contacts

Ana M Arbelaez, MD

Role: primary

Other Identifiers

201801029

Identifier Type: -

Identifier Source: org_study_id