RECRUITING

Utility of 18FDOPA PET/MRI for Focal Hyperinsulinism

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Conditions

HyperinsulinismhypoglycemiaGlucose Metabolism DisordersInfant, Newborn, DiseasesInsulinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to provide access to 18F-DOPA PET to patients at Washington University and assess the utility of 18F-DOPA PET/MRI as a preoperative tool to detect and localize focal lesions in the pancreas that are causing hyperinsulinism.

Official Title

Use of18F-DOPA PET/MRI for the Detection and Localization of Focal Forms of Hyperinsulinism

Quick Facts

Study Start:2020-09-10
Study Completion:2030-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05088798

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients with confirmed hyperinsulinemic hypoglycemia, diagnosed by elevated insulin levels during hypoglycemia and/or response to glucagon stimulation.
  2. 2. Subjects who failed pharmacological therapy with diazoxide or octreotide.
  3. 3. Subjects with signed informed consent by themselves or their parents or legal guardians.
  4. 4. Patient's Endocrinologist has determined that the patient cannot be safely managed with standard medical therapy (failed) and surgery is recommended to prevent future episodes of severe hypoglycemia and preserve brain function.
  1. 1. Any other major illness or condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in this study.
  2. 2. Patient must not have any contraindication to MRI as evaluated by a standardized MRI safety questionnaire. If MRI is contraindicated, and patient meets inclusion criteria and has no other contraindications study will be conducted in PET/CT scanner.
  3. 3. Cases in which surgery will not be considered by parents or guardians.

Contacts and Locations

Principal Investigator

Ana Maria Arbelaez, MD, MSCI
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Ana Maria Arbelaez, MD, MSCI, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

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

Study Start Date2020-09-10
Study Completion Date2030-01-01

Study Record Updates

Study Start Date2020-09-10
Study Completion Date2030-01-01

Terms related to this study

Keywords Provided by Researchers

  • hypoglycemia
  • Glucose Metabolism Disorders
  • Infant, Newborn, Diseases
  • Hyperinsulinism
  • Insulinoma

Additional Relevant MeSH Terms

  • Hyperinsulinism