Clinical Trial: Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia

Study Status: Available
Recruit Status: Available
Study Type: Expanded Access

Official Title: Phase II Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia

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 Summary: 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.
Sponsor: Baylor College of Medicine

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Baylor College of Medicine

Dates:
Date Received: August 24, 2015
Date Started:
Date Completion:
Last Updated: October 10, 2016
Last Verified: October 2016