Trial record 1 of 5 for:    "Beckwith-Wiedemann syndrome"
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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 February 2016 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: February 18, 2016
Last verified: February 2016
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
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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

United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Lisa States, MD         
Sponsors and Collaborators
Children's Hospital of Philadelphia
Principal Investigator: Lisa States, MD Children's Hospital of Philadelphia
  More Information

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: February 18, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:

Additional relevant MeSH terms:
Beckwith-Wiedemann Syndrome
Congenital Hyperinsulinism
Abnormalities, Multiple
Adenoma, Islet Cell
Chromosome Disorders
Congenital Abnormalities
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genetic Diseases, Inborn
Glucose Metabolism Disorders
Infant, Newborn, Diseases
Metabolic Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Pancreatic Neoplasms processed this record on April 27, 2016