Trials / Completed
CompletedNCT01468454
Phase II Safety and Efficacy Study of 18FDOPA PET-CT in Children With Hyperinsulinemic Hypoglycemia
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 130 (actual)
- Sponsor
- Children's Hospital of Philadelphia · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
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 (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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 18 F-DOPA | 1 time injection of 0.08 - 0.16 mCi/kg of 18F-DOPA |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2014-06-01
- Completion
- 2018-02-01
- First posted
- 2011-11-09
- Last updated
- 2022-10-13
- Results posted
- 2021-10-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01468454. Inclusion in this directory is not an endorsement.