Trials / No Longer Available
No Longer AvailableNCT02533219
Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia
Phase II Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Baylor College of Medicine · Academic / Other
- Sex
- All
- Age
- 64 Years
- Healthy volunteers
- —
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.
Conditions
- Hyperinsulinemic Hypoglycemia, Persistent
- Congenital Hyperinsulinism
- Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 18 F-DOPA | 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. |
Timeline
- First posted
- 2015-08-26
- Last updated
- 2020-09-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02533219. Inclusion in this directory is not an endorsement.