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Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism

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ClinicalTrials.gov Identifier: NCT00674440
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : February 19, 2018
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Lisa States, Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE May 5, 2008
First Posted Date  ICMJE May 7, 2008
Last Update Posted Date February 19, 2018
Study Start Date  ICMJE December 2004
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
The ability of FDOPA PET to identify forms of hyperinsulinism that may be cured by surgery: focal forms. [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00674440 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
Assess safety of F-DOPA PET. [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism
Official Title  ICMJE Localization of Focal Forms of Hyperinsulinism of Infancy With 18F-labeled L-fluoro-DOPA PET Scan
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Congenital Hyperinsulinism
  • Hyperinsulinism
  • Persistent Hyperinsulinemic Hypoglycemia of Infancy
  • CHI
  • PHHI
Intervention  ICMJE
  • Drug: F-DOPA
    0.08-0.16 mCi/kg once
    Other Names:
    • 18F-labeled L-fluorodeoxyphenylalanine
    • 18F-DOPA
  • Radiation: PET scan
Study Arms  ICMJE
  • Experimental: 1
    Children diagnosed with hyperinsulinism who have failed other non-surgical interventions and will be scheduled for surgery. Eligible children in this arm will PET imaging with F-DOPA prior to surgery.
    Interventions:
    • Drug: F-DOPA
    • Radiation: PET scan
  • Experimental: 3
    Children diagnosed with hyperinsulinism who have had partial pancreas removal but still display signs of hyperinsulinism. Eligible children in this arm may have PET imaging with F-DOPA.
    Interventions:
    • Drug: F-DOPA
    • Radiation: PET scan
  • Experimental: 2
    Children diagnosed with hyperinsulinism who are successfully managed with diazoxide, octreotide, other medications,and/or tube feedings. Eligible children in this arm will PET imaging with F-DOPA.
    Interventions:
    • Drug: F-DOPA
    • Radiation: PET scan
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2011)
105
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2008)
100
Actual Study Completion Date  ICMJE February 2018
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00674440
Other Study ID Numbers  ICMJE 04-003683
FD-R-003457-01 ( Other Grant/Funding Number: FDA orphan drug grant )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lisa States, Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE University of Pennsylvania
Investigators  ICMJE
Principal Investigator: Lisa J States, MD Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date February 2018

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