18F-DOPA PET/CT scan for Hyperinsulinism

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This study is sponsored by Children's Hospital of Philadelphia Department of Radiology.

The purpose of this research is to study 18F-L-Fluoro-DOPA (F-DOPA), a tracer, which is used to take pictures of the pancreas. This imaging test is called an F-DOPA PET scan. The F-DOPA tracer is used to highlight areas of the pancreas that make too much insulin on the PET scan images. The test includes a CT scan (computerized tomography) done at the same time on the same machine, to help define exactly where the highlighted area is located within the pancreas and determine the location of blood vessels and other vital structures.

Who can participate:

  • Infants, children and adults with hyperinsulinemic hypoglycemia, diagnosed by a fasting test and/or response to glucagon stimulation
  • Any age, from birth on
  • Requiring surgery to remove part or all of the pancreas

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at beckers [at] chop.edu or 267-426-0269.

ClinicalTrials.gov Identifier

NCT01916148

View full trial information on ClinicalTrials.gov

Eligibility & Criteria

IRB #:
12-009528
Official Title:
Expanded Access Use of 18f-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects with Hyperinsulinemic Hypoglycemia
Study Phase:
Not Applicable
Eligible Age Range:
0 - 99 Years
Gender:
All
Study Categories:

Visit Criteria

If the HI team decides your child qualifies for this study, you will be asked to participate prior to the scheduled surgery.

The process you and your child will undergo includes:

  • An interview to collect your families' medical information.
  • Physical examination of your child.
  • Blood sample collection.
  • Intravenous catheter.
  • Anesthesia or sedation for PET/CT scan depending on the patient's age.
  • Fasting, if the test being done is under sedation or anesthesia.
  • F-DOPA injection.
  • PET/CT scan.

Eligible patients that consent to participate will have their scan done at least one day before surgery.

Participation in this study will last for the length of the admission for surgery.

Participants will not receive any compensation for participation in this study. All study-related care and study drug will be charged to you and your insurance company as part of the admission.

Please note: Participation is voluntary and you may quit the study at any time, for any reason.

Leader
Lisa J. States

Lisa J. States, MD