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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 January 2017 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: January 31, 2017
Last verified: January 2017
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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All

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
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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: January 31, 2017

Keywords provided by Children's Hospital of Philadelphia:

Additional relevant MeSH terms:
Congenital Hyperinsulinism
Beckwith-Wiedemann Syndrome
Glucose Metabolism Disorders
Metabolic Diseases
Adenoma, Islet Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Infant, Newborn, Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn processed this record on May 23, 2017