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

Congenital Hyperinsulinism Clinical Trial

— [18F]-DOPA  

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02533219
• Other study ID #: H-32432
• Status: No longer available

Study information

• Verified date: September 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: N/A to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Hyperinsulinism
• Hyperinsulinemic Hypoglycemia, Persistent
• Hyperinsulinism
• Hypoglycemia
• Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States,