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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 October 2014 by Children's Hospital of Philadelphia
Sponsor:
Information provided by (Responsible Party):
Lisa States, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01916148
First received: July 30, 2013
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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
Insulinoma
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.
  Eligibility

Genders Eligible for Study:   Both
Criteria

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 ClinicalTrials.gov identifier: NCT01916148

Contacts
Contact: Susan Becker, RN, BSN, CCRC 267-426-0269 Beckers@email.chop.edu
Contact: Lisa States, MD 267-425-7146 States@email.chop.edu

Sponsors and Collaborators
Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Lisa States, Principal Investigator, Children's Hospital of Philadelphia
ClinicalTrials.gov 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:
Hypoglycemia
Hyperinsulinism

Additional relevant MeSH terms:
Insulinoma
Beckwith-Wiedemann Syndrome
Congenital Hyperinsulinism
Hyperinsulinism
Hypoglycemia
Abnormalities, Multiple
Adenoma
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
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Pancreatic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014