- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02533219
Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia ([18F]-DOPA)
September 3, 2020 updated by: Victor J. Seghers, Baylor College of Medicine
Phase II Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia
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.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
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.
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 62 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
August 24, 2015
First Submitted That Met QC Criteria
August 25, 2015
First Posted (Estimate)
August 26, 2015
Study Record Updates
Last Update Posted (Actual)
September 7, 2020
Last Update Submitted That Met QC Criteria
September 3, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Infant, Newborn, Diseases
- Pancreatic Diseases
- Hypoglycemia
- Hyperinsulinism
- Congenital Hyperinsulinism
- Nesidioblastosis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dopamine Agents
- Dihydroxyphenylalanine
Other Study ID Numbers
- H-32432
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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