Phase II Safety and Efficacy Study of F-DOPA PET/CT in Children With Hyperinsulinemic Hypoglycemia
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery to remove part or all of their pancreas. In this study, researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine (called F-DOPA) can detect a form of hyperinsulinism (focal HI) that may be cured by surgery. Eligible participants in this study will have positron emission tomography/computerized tomography (PET/CT) scans with F-DOPA prior to surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Congenital Hyperinsulinism Persistent Hyperinsulinemic Hypoglycemia of Infancy Pancreatectomy |
Drug: 18 F-DOPA PET/CT imaging |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Phase II Safety and Efficacy Study of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Children With Hyperinsulinemic Hypoglycemia |
- Ability of 18F-DOPA PET/CT scans to detect focal lesions in infants and children with congenital hyperinsulinism [ Time Frame: within 7 days following PET ] [ Designated as safety issue: No ]To determine the accuracy of localization, sensitivity, specificity of 18F-DOPA PET/CT in detecting a focal lesion in children with HI.
- Safety of 18F-DOPA PET/CT scan [ Time Frame: up to 4 weeks after F-DOPA administration or hospital discharge ] [ Designated as safety issue: Yes ]
To further evaluate the safety of 18-labeled L-fluorodeoxyphenylalanine (18F-DOPA) PET/CT imaging in infants and children with congenital hyperinsulinism
- subjects are monitored clinically for any signs or symptoms of adverse events for 72 hours post PET. Adverse events are documented and followed to resolution
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: (18F-DOPA) PET/CT imaging
Obtain safety and efficacy data on the use of 18-labeled L-fluorodeoxyphenylalanine (18F-DOPA) PET imaging in children with HI for the clinical indication of localizing a focal lesion
|
Drug: 18 F-DOPA PET/CT imaging
one time injection of 0.08 - 0.16 mCurie/kg of 18F-DOPA
Other Name: 18 F-DOPA PET/CT imaging
|
Detailed Description:
For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas (called diffuse disease); others have them located in specific areas of the pancreas (called focal disease). Children who have focal disease located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that is picked up by these cells and used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will validate the efficacy and safety of using PET/CT with F-DOPA in the pre-operative localization of focal disease in children with hyperinsulinism.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Infants and children with a clinical diagnosis of hyperinsulinism who are suspected to have focal disease and are surgical candidates for pancreatectomy
Exclusion Criteria:
- Pregnant or lactating females
- Any other major illness or condition that might substantially increase the risk associated with the subject's participation in this study.
Contacts and Locations| Contact: Lisa J States, MD | 267- 425-7146 | states@email.chop.edu |
| Contact: Susan A Becker, RN, BSN | 267-426-0269 | beckers@email.chop.edu |
| United States, Pennsylvania | |
| The Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Lisa J States, MD | Children's Hospital of Philadelphia |
More Information
Additional Information:
Publications:
| Responsible Party: | Lisa States, Principal Investigator, Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT01468454 History of Changes |
| Other Study ID Numbers: | 08-006211 |
| Study First Received: | October 18, 2011 |
| Last Updated: | January 17, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Children's Hospital of Philadelphia:
|
Congenital Hyperinsulinism hyperinsulinism Persistent Hyperinsulinemic Hypoglycemia of Infancy |
CHI PHHI 18F-DOPA |
Additional relevant MeSH terms:
|
Hyperinsulinism Persistent Hyperinsulinemia Hypoglycemia of Infancy Hypoglycemia Nesidioblastosis Glucose Metabolism Disorders Metabolic Diseases Pancreatic Diseases Digestive System Diseases |
Infant, Newborn, Diseases Dihydroxyphenylalanine Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013