Phase II Safety and Efficacy Study of F-DOPA PET/CT in Children With Hyperinsulinemic Hypoglycemia
This trial is active, not recruiting.
|Conditions||congenital hyperinsulinism (chi), persistent hyperinsulinemic hypoglycemia of infancy (phhi)|
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
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
Safety of 18F-DOPA PET/CT scan
time frame: up to 4 weeks after F-DOPA administration or hospital discharge
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.
|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.|
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