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Phase II Safety and Efficacy Study of F-DOPA PET/CT in Children With Hyperinsulinemic Hypoglycemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Lisa States, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01468454
First received: October 18, 2011
Last updated: February 12, 2014
Last verified: February 2014

October 18, 2011
February 12, 2014
January 2009
December 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
To determine the accuracy of localization, sensitivity, specificity of 18F-DOPA PET/CT in detecting a focal lesion in children with HI.
Same as current
Complete list of historical versions of study NCT01468454 on ClinicalTrials.gov Archive Site
Safety of 18F-DOPA PET/CT scan [ Time Frame: up to 4 weeks after F-DOPA administration or hospital discharge ] [ Designated as safety issue: Yes ]

To further evaluate the safety of 18-labeled L-fluorodeoxyphenylalanine (18F-DOPA) PET/CT imaging in infants and children with congenital hyperinsulinism

- subjects are monitored clinically for any signs or symptoms of adverse events for 72 hours post PET. Adverse events are documented and followed to resolution

Same as current
Not Provided
Not Provided
 
Phase II Safety and Efficacy Study of F-DOPA 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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Congenital Hyperinsulinism (CHI)
  • Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
Drug: 18 F-DOPA
one time injection of 0.08 - 0.16 mCurie/kg of 18F-DOPA
Experimental: (18F-DOPA) PET/CT imaging
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
Intervention: Drug: 18 F-DOPA

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01468454
08-006211
No
Lisa States, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
University of Pennsylvania
Principal Investigator: Lisa J States, MD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP