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
  Purpose

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.


Condition Intervention Phase
Congenital Hyperinsulinism (CHI)
Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
Drug: 18 F-DOPA
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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



Estimated Enrollment: 300
Study Start Date: January 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: 18 F-DOPA
one time injection of 0.08 - 0.16 mCurie/kg of 18F-DOPA

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468454

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
University of Pennsylvania
Investigators
Principal Investigator: Lisa J States, MD Children's Hospital of Philadelphia
  More Information

Additional Information:
Publications:

Responsible Party: Lisa States, Principal Investigator, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01468454     History of Changes
Other Study ID Numbers: 08-006211
Study First Received: October 18, 2011
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
Congenital Hyperinsulinism (CHI)
hyperinsulinism
Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
CHI
PHHI
Pancreatectomy
18F-DOPA
PET/CT scan

Additional relevant MeSH terms:
Hyperinsulinism
Hypoglycemia
Nesidioblastosis
Persistent Hyperinsulinemia Hypoglycemia of Infancy
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Dihydroxyphenylalanine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014