Back to resultsStudy of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia ([18F]-DOPA)
Primary Purpose
Hyperinsulinemic Hypoglycemia, Persistent, Congenital Hyperinsulinism, Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
18 F-DOPA
Sponsored by
About this trial
This is an expanded access trial for Hyperinsulinemic Hypoglycemia, Persistent focused on measuring Hyperinsulinemic hypoglycemia, PET/CT, PET/MRI, [18F]-DOPA, PET/MR, Congenital Hyperinsulinism
Eligibility Criteria
Inclusion Criteria:
- All Patients clinically diagnosed with Hyperinsulinemia of any age
- Patients in need of PET scan
- Patients that require sedation
- Patients that do not require sedation
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
- Patients without Hyperinsulinemia
- Patients who are or may be pregnant
- Serious intercurrent medical illness other than hypoglycemia that precludes having the scan either because of patient instability or concerns about potential toxicity.
- Patient's requiring emergency surgical intervention that would be inappropriately delayed by [18F]-DOPA PET imaging.
Sites / Locations
- Texas Children's Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02533219
First Posted
August 24, 2015
Last Updated
September 3, 2020
Sponsor
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02533219
Brief Title
Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia
Acronym
[18F]-DOPA
Official Title
Phase II Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the utility of [18F]-DOPA PET to provide improved presurgical planning and distinguish between focal and diffuse forms of HI. The investigators will perform descriptive analysis, relying on visual analysis to diagnose and localize a focal lesion. Our findings will be compared to surgical histopathology to determine sensitivity and specificity or this technique. The investigators will also track patient surgical outcomes, specifically whether the patient is surgically "cured" or still requires medical management to control residual hypoglycemia.
Detailed Description
Hyperinsulinemic hypoglycemia is caused by low glucose due to excessive insulin secretion and remains difficult to treat because of the requirement for extensive amounts of glucose and the lack of effective long-term medical therapy. Correct diagnosis, localization, and limited excision of the focal lesion will result in a complete cure of the patient. In contrast, medically unresponsive diffuse disease requires a near total pancreatectomy, greatly increasing the risk of future diabetes mellitus. Fortunately, [18F]-DOPA PET has been shown to be a useful noninvasive imaging method for distinguishing between focal and diffuse forms of hyperinsulinemic hypoglycemia. In this study, the investigators seek to validate the effectiveness of using PET/MR and PET/CT with F-DOPA to accurately and reliably detect and localize disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperinsulinemic Hypoglycemia, Persistent, Congenital Hyperinsulinism, Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
Keywords
Hyperinsulinemic hypoglycemia, PET/CT, PET/MRI, [18F]-DOPA, PET/MR, Congenital Hyperinsulinism
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
18 F-DOPA
Other Intervention Name(s)
Fluorine-18-L-dihydroxyphenylalanine
Intervention Description
Subjects will undergo PET imaging with [18F]-DOPA. All PET imaging will be performed after administration of a single dose (0.08 - 0.16 mCurie/kg) of [18F]-DOPA. PET imaging can be performed on either Philips Ingenuity TF PET/MRI or PET/CT.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
64 Years
Eligibility Criteria
Inclusion Criteria:
All Patients clinically diagnosed with Hyperinsulinemia of any age
Patients in need of PET scan
Patients that require sedation
Patients that do not require sedation
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
Patients without Hyperinsulinemia
Patients who are or may be pregnant
Serious intercurrent medical illness other than hypoglycemia that precludes having the scan either because of patient instability or concerns about potential toxicity.
Patient's requiring emergency surgical intervention that would be inappropriately delayed by [18F]-DOPA PET imaging.
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia
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