Official study name: Expanded Access Use of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia
Sponsor/investigator: Lisa J. States, MD
The Children’s Hospital of Philadelphia Department of Radiology
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
What is this study about?
The purpose of this research is to study 18F-L-Fluoro-DOPA (F-DOPA), a radioactive drug (tracer), which is used in a nuclear medicine test 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.
What does participation involve?
If the HI team decides your child qualifies for this study, you will be asked 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 for testing
- Intravenous catheter
- anesthesia or sedation for PET/CT scan depending on age
- Fasting if test being done under sedation or anesthesia
- F-DOPA injection and PET/CT scan
Eligible patients that consent to participate will have their scan done at least one day before surgery.
A few things you should know about participating in the 18F-DOPA PET/ CT scan\study:
- Participation is voluntary and you may quit the study at any time, for any reason
- Regardless of whether or not you receive the investigational product (18F-DOPA), all eligible patients will receive surgery from expert medical staff.
How long will this study last?
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 or your insurance company as part of the admission.
If you are interested in the study
Please contact study coordinator, Susan Becker 267-426-0269 or firstname.lastname@example.org. Clinicians can also contact the PI, Dr. Lisa States.
For more information, please visit www.clinicaltrials.gov and search for NCT01916148
CHOP IRB#: 12-009528
Initial Effective Date: 7/30/2013 (expected to be open for ~10 years)