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

Expanded access is currently available for this treatment.
Verified October 2016 by Victor J. Seghers, Baylor College of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02533219
First Posted: August 26, 2015
Last Update Posted: October 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Texas Children's Hospital
Information provided by (Responsible Party):
Victor J. Seghers, Baylor College of Medicine
  Purpose
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.

Condition Intervention
Hyperinsulinemic Hypoglycemia, Persistent Congenital Hyperinsulinism Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI) Drug: 18 F-DOPA

Study Type: Expanded Access     What is Expanded Access?
Official Title: Phase II Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia

Resource links provided by NLM:


Further study details as provided by Victor J. Seghers, Baylor College of Medicine:

Intervention Details:
    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.
    Other Name: Fluorine-18-L-dihydroxyphenylalanine
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533219


Contacts
Contact: Victor Seghers, PhD, MD 832-822-0429 vjsegher@texaschildrens.org

Locations
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Contact: Victor Seghers, PhD, MD    832-822-0429    vjsegher@texaschildrens.org   
Sponsors and Collaborators
Baylor College of Medicine
Texas Children's Hospital
  More Information

Responsible Party: Victor J. Seghers, Assistant Professor of Radiology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02533219     History of Changes
Other Study ID Numbers: H-32432
First Submitted: August 24, 2015
First Posted: August 26, 2015
Last Update Posted: October 12, 2016
Last Verified: October 2016

Keywords provided by Victor J. Seghers, Baylor College of Medicine:
Hyperinsulinemic hypoglycemia
PET/CT
PET/MRI
[18F]-DOPA
PET/MR
Congenital Hyperinsulinism

Additional relevant MeSH terms:
Hyperinsulinism
Congenital Hyperinsulinism
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Dihydroxyphenylalanine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs