NCT02533219

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
Last Updated

September 7, 2020

Status Verified

September 1, 2020

First QC Date

August 24, 2015

Last Update Submit

September 3, 2020

Conditions

Hyperinsulinemic Hypoglycemia, PersistentCongenital HyperinsulinismPersistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)

Keywords

Hyperinsulinemic hypoglycemiaPET/CTPET/MRI[18F]-DOPAPET/MRCongenital Hyperinsulinism

Interventions

18 F-DOPADRUG

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.

Also known as: Fluorine-18-L-dihydroxyphenylalanine

Eligibility Criteria

AgeUp to 64 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Congenital Hyperinsulinism

Interventions

fluorodopa F 18

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHypoglycemia

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Radiology

Study Record Dates

First Submitted

August 24, 2015

First Posted

August 26, 2015

Last Updated

September 7, 2020

Record last verified: 2020-09

Locations

US(1)