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

NCT02533219 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2020-09-07

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Eligibility

Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02533219 on ClinicalTrials.gov