This trial is active, not recruiting.

Conditions congenital hyperinsulinism (chi), persistent hyperinsulinemic hypoglycemia of infancy (phhi)
Treatment 18 f-dopa
Phase phase 2
Sponsor Children's Hospital of Philadelphia
Collaborator University of Pennsylvania
Start date January 2009
End date June 2014
Trial size 128 participants
Trial identifier NCT01468454, 08-006211


Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery to remove part or all of their pancreas. In this study, researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine (called F-DOPA) can detect a form of hyperinsulinism (focal HI) that may be cured by surgery. Eligible participants in this study will have positron emission tomography/computerized tomography (PET/CT) scans with F-DOPA prior to surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Obtain safety and efficacy data on the use of 18-labeled L-fluorodeoxyphenylalanine (18F-DOPA) PET imaging in children with HI for the clinical indication of localizing a focal lesion
18 f-dopa
one time injection of 0.08 - 0.16 mCurie/kg of 18F-DOPA

Primary Outcomes

Ability of 18F-DOPA PET/CT scans to detect focal lesions in infants and children with congenital hyperinsulinism
time frame: within 7 days following PET

Secondary Outcomes

Safety of 18F-DOPA PET/CT scan
time frame: up to 4 weeks after F-DOPA administration or hospital discharge

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Infants and children with a clinical diagnosis of hyperinsulinism who are suspected to have focal disease and are surgical candidates for pancreatectomy Exclusion Criteria: - Pregnant or lactating females - Any other major illness or condition that might substantially increase the risk associated with the subject's participation in this study.

Additional Information

Official title A Phase II Safety and Efficacy Study of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Children With Hyperinsulinemic Hypoglycemia
Principal investigator Lisa J States, MD
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 (called diffuse disease); others have them located in specific areas of the pancreas (called focal disease). Children who have focal disease located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that is picked up by these cells and used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will validate the efficacy and safety of using PET/CT with F-DOPA in the pre-operative localization of focal disease in children with hyperinsulinism.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Children's Hospital of Philadelphia.