Trial record 10 of 11 for:
"Persistent Hyperinsulinemia Hypoglycemia of Infancy" OR "familial hyperinsulinism"
18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia
Expanded access is currently available for this treatment.
Verified October 2014 by Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Lisa States, Children's Hospital of Philadelphia
First received: July 30, 2013
Last updated: October 7, 2014
Last verified: October 2014
This purpose of this study is to determine the ability of an 18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET scan to detect a focal lesion of hyperinsulinism and determine the location in patients with congenital hyperinsulinism, Beckwith Wiedemann Syndrome and suspected insulinoma. Safety data will be collected.
What is Expanded Access?
||Expanded Access Use of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia
|Genders Eligible for Study:
- Subjects of any age with hyperinsulinemic hypoglycemia, diagnosed by a fasting test and/or response to glucagon stimulation.
- Subjects who are eligible for pancreatic surgery regardless of prior pancreatic surgery
- Pregnant or lactating females
- Any other major illness or condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in this study
- Subjects who are not a candidate for pancreatic surgery
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01916148
Children's Hospital of Philadelphia
No publications provided
||Lisa States, Principal Investigator, Children's Hospital of Philadelphia
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 30, 2013
||October 7, 2014
||United States: Food and Drug Administration
Keywords provided by Children's Hospital of Philadelphia:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2015
Adenoma, Islet Cell
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genetic Diseases, Inborn
Glucose Metabolism Disorders
Infant, Newborn, Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial