Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism

Phase 2

Completed

• Conditions: Congenital Hyperinsulinism; Hyperinsulinism; Persistent Hyperinsulinemic Hypoglycemia of Infancy; CHI; PHHI
• Interventions: Drug: F-DOPA; Radiation: PET scan

• Registration Number: NCT00674440
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible participants in this study will have positron emission tomography (PET) scans with F-DOPA prior to surgery.

Detailed Description

For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas; others have them located in specific areas of the pancreas. Children who have them located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that may go to these very cells. F-DOPA can also be used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will test the possibility of using PET with F-DOPA in the diagnosis of children with hyperinsulinism.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-05
• Study First Posted: 2008-05-07
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Disposition First Submitted: 2013-01-25
• Disposition First Submitted QC: 2013-01-25
• Disposition First Posted: 2013-01-29
• Results First Submitted: 2022-07-20
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-11
• Last Update Submitted: 2022-10-11
• Results First Posted: 2022-11-09
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Any age, but primarily infants 0-6 months.
• Children with confirmed diagnosis of congenital hyperinsulinism.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects who had PET and surgery	PET scan	Children diagnosed with hyperinsulinism who have failed other non-surgical interventions and are candidates to be scheduled for surgery for partial pancreatectomy. Eligible children will undergo PET imaging with F-DOPA prior to surgery.
Subjects who had PET and surgery	F-DOPA	Children diagnosed with hyperinsulinism who have failed other non-surgical interventions and are candidates to be scheduled for surgery for partial pancreatectomy. Eligible children will undergo PET imaging with F-DOPA prior to surgery.

Primary Outcome Measures

Name	Time	Method
The Accuracy of FDOPA PET to Identify Focal Forms of Hyperinsulinism	up to 1 month post surgical intervention	Comparison of PET scan results with outcome of surgery and histopathology results confirmed as focal or diffuse

Secondary Outcome Measures

Name	Time	Method
Safety of F-DOPA PET	72 hours maximum or prior to pancreatic surgery	Number of Participants with Adverse Events

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States