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18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism (DOPA PET)

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. Identifier: NCT04205604
Recruitment Status : Recruiting
First Posted : December 19, 2019
Last Update Posted : December 19, 2019
Information provided by (Responsible Party):
Miguel Pampaloni, University of California, San Francisco

Brief Summary:
The goal of this project is to determine the role of FDOPA/PET as a pre-operative diagnostic imaging procedure for differentiating focal and diffuse forms of congenital hyperinsulinism and locating focal lesions in the pancreas to guide surgical resection.

Condition or disease Intervention/treatment Phase
Congenital Hyperinsulinism Diagnostic Test: 18F-Fluoro Dopa Imaging Phase 1

Detailed Description:
Congenital hyperinsulinism (HI) is the most common cause of recurrent and persistent hypoglycemia, presenting early in infancy. Patients who fail medical therapy usually require resection of the diseased pancreas(partial or subtotal pancreatectomy) to control this disorder. Over half of patients undergoing surgery have a focal area of islet cell dysfunction that is curable with resection. These focal lesions are areas of adenomatosis consisting of a clone of beta-cells that express a paternally-derived mutation of the KATP channel due to loss of heterozygosity for the maternal allele. Current imaging techniques cannot differentiate focal and diffuse forms of hyperinsulinism, nor can they locate focal areas of disease within the pancreas before surgery. L-DOPA is taken up by some neuroendocrine cells, including pancreatic islet cells, and stored as dopamine in secretory granules. Recent studies show that positron emission tomography (PET) following administration of 18F-fluoro-L-DOPA (FDOPA) can distinguish focal and diffuse forms of HI and accurately locate focal lesions within the pancreas.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-Fluoro-L- DOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
Actual Study Start Date : November 3, 2016
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Single Arm,
Patients with clinically diagnosed congenital hyperinsulinism
Diagnostic Test: 18F-Fluoro Dopa Imaging
Imaging with 18F-Fluoro Dopa PET Imaging

Primary Outcome Measures :
  1. Sensitivity of Imaging [ Time Frame: four weeks ]
    To determine the sensitivity and specificity of FDOPA PET/CT in differentiating focal and diffuse forms of HI in infants with medically refractory hypoglycemia

  2. Accuracy of Imaging [ Time Frame: four weeks ]
    To determine the accuracy of FDOPA PET/CT localizing areas of islet cell adenomatosis within the pancreas in patients with focal HI, by identifying the area of abnormal uptake of the raioligand

Secondary Outcome Measures :
  1. Semiquantitative Imaging Assessment [ Time Frame: four weeks ]
    o determine whether data from FDOPA PET/CT can accurately quantify pancreatic islet cell mass in patients with HI (normal pancreas, areas of adenomatosis in focal HI and diseased pancreas in diffuse HI) by quantifying the standardized uptake value (SUV) of FDOPA of and correlating with histologic findings.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


.Any age, but primarily infants 0-6 months given typical age of initial presentation.

  • Children with diagnosis of FoHI or DiHI based on clinical criteria (fasting hypoglycemia accompanied by inadequate suppression of plasma insulin, inappropriately low plasma free fatty acid and plasma-hydroxybutyrate concentrations, and an inappropriate glycemic response to glucagon injection) .confirmed by genetic testing for mutations in ABCC8 and KCNJ1 was1. .Hypoglycemia uncontrolled with medical management (diazoxide, octreotide). .Able to withdraw medications in time to wash out prior to the scheduled PET scan.
  • Patients fulfilling criteria above but with uncontrolled hypoglycemia after initial surgical management (partial or near-total pancreatectomy) .Normal hepatic and renal function.

Exclusion Criteria:

.Treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon).

.Patients with hepatic or renal insufficiency.

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 identifier (NCT number): NCT04205604

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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Miguel Hernandez Pampaloni, MD, PhD    415-353-1886      
Sponsors and Collaborators
University of California, San Francisco

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Responsible Party: Miguel Pampaloni, Associate Professor of Radiology & Medicine, University of California, San Francisco Identifier: NCT04205604    
Other Study ID Numbers: 8F-Fluoro-L- DOPA
First Posted: December 19, 2019    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Congenital Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases