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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01468454
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : February 19, 2018
University of Pennsylvania
Information provided by (Responsible Party):
Lisa States, Children's Hospital of Philadelphia

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2009
Actual Primary Completion Date : June 2014
Actual Study Completion Date : February 2018

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Safety of 18F-DOPA PET/CT scan [ Time Frame: up to 4 weeks after F-DOPA administration or hospital discharge ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01468454

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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
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Principal Investigator: Lisa J States, MD Children's Hospital of Philadelphia

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Lisa States, Principal Investigator, Children's Hospital of Philadelphia Identifier: NCT01468454     History of Changes
Other Study ID Numbers: 08-006211
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Keywords provided by Lisa States, Children's Hospital of Philadelphia:
Congenital Hyperinsulinism (CHI)
Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
PET/CT scan
Additional relevant MeSH terms:
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Congenital Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs