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

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

Tracking Information
First Submitted Date  ICMJE December 16, 2019
First Posted Date  ICMJE December 19, 2019
Last Update Posted Date December 19, 2019
Actual Study Start Date  ICMJE November 3, 2016
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
Official Title  ICMJE 18F-Fluoro-L- DOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Congenital Hyperinsulinism
Intervention  ICMJE Diagnostic Test: 18F-Fluoro Dopa Imaging
Imaging with 18F-Fluoro Dopa PET Imaging
Study Arms  ICMJE Experimental: Single Arm,
Patients with clinically diagnosed congenital hyperinsulinism
Intervention: Diagnostic Test: 18F-Fluoro Dopa Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 17, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04205604
Other Study ID Numbers  ICMJE 8F-Fluoro-L- DOPA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Miguel Pampaloni, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, San Francisco
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP