Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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 Identifier:
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.

Condition Intervention
Congenital Hyperinsulinism
Beckwith-Wiedemann Syndrome
Drug: 18F-DOPA

Study Type: Expanded Access     What is Expanded Access?
Official Title: Expanded Access Use of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia

Resource links provided by NLM:

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

Intervention Details:
    Drug: 18F-DOPA
    18F-DOPA is a PET scan radiotracer.

Genders Eligible for Study:   Both

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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 identifier: NCT01916148

Contact: Susan Becker, RN, BSN, CCRC 267-426-0269
Contact: Lisa States, MD 267-425-7146

Sponsors and Collaborators
Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Lisa States, Principal Investigator, Children's Hospital of Philadelphia Identifier: NCT01916148     History of Changes
Other Study ID Numbers: 12-009528
Study First Received: July 30, 2013
Last Updated: October 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:

Additional relevant MeSH terms:
Congenital Hyperinsulinism
Beckwith-Wiedemann Syndrome
Abnormalities, Multiple
Chromosome Disorders
Congenital Abnormalities
Digestive System Diseases
Genetic Diseases, Inborn
Glucose Metabolism Disorders
Infant, Newborn, Diseases
Metabolic Diseases
Pancreatic Diseases processed this record on March 03, 2015