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Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma

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ClinicalTrials.gov Identifier: NCT02021604
Recruitment Status : Recruiting
First Posted : December 27, 2013
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Cook Children's Health Care System

Brief Summary:

Low blood sugars are known to cause brain damage in newborn babies. One of the most common causes of low blood sugars persisting beyond the new born period is a condition called congenital hyperinsulinism (HI). This is a disease whereby the pancreas secretes too much insulin and causes low blood sugars. Twenty to forty percent of these babies will have brain damage. There are two forms of this disease. In one form only a small part of the pancreas makes too much insulin (focal HI) and in the other, the whole pancreas make too much insulin (diffuse HI). Another very similar disease is insulinoma which occurs after birth, but also causes hyperinsulinism. If a surgeon could know which part of the pancreas has the focal lesion he could remove it and cure the patient.

The purpose of this study is to investigate whether a new investigational drug called Fluorodopa F 18, when used with a PET scan, can find the focal lesion and guide the surgeon to remove it, thus curing the patient and preventing further brain damage.


Condition or disease Intervention/treatment Phase
Congenital Hyperinsulinism Insulinoma Drug: Fluorodopa F 18 Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: The Use of Fluorodopa F 18 Positron Emission Tomography Combined With Computed Tomography in Congenital Hyperinsulinism and Insulinoma
Actual Study Start Date : October 9, 2013
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : June 2028


Arm Intervention/treatment
Experimental: Pancreatic Imaging with Fluorodopa F 18 Drug: Fluorodopa F 18
A dose of Fluorodopa F 18, 3-6 MBq/Kg (0.08-0.16 mCi/kg), will be injected intravenously into the subject under the direct supervision of the radiology sub-investigator. Then, the PET imaging procedure will begin and proceed for up to 70 minutes after injection. An abdominal CT image will be made using intravenous contrast. Both images, PET and CT, will be co-localized by the radiologist for interpretation.
Other Names:
  • Fluorodopa 18F (International Non-Proprietary Name)
  • 6-[18F]fluorolevodopa (U.S. Pharmacopeia)
  • Fluorodopa F 18 (CAS Number 75290-51-6)




Primary Outcome Measures :
  1. Radioactivity of 18F-DOPA following transport [ Time Frame: 1 day ]
    Positron Emission Tomography will be used to determine whether or not the uptake of a radiopharmaceutical agent, Fluorodopa F 18, produced in a cyclotron located at a distance far from the imaging center will produce qualitatively adequate pancreatic images in patients with congenital hyperinsulinism

  2. Accuracy of PET imaging compared to intraoperative pancreatic biopsy in patients with congenital hyperinsulinism [ Time Frame: up to one month ]
    Investigators will directly compare pancreatic images from Fluorodopa F 18 PET combined with Computed Tomography versus the gold-standard of histopathological findings at surgery in subjects who received a partial or complete pancreatectomy


Secondary Outcome Measures :
  1. Accuracy of PET imaging compared to intraoperative pancreatic biopsy in patients with insulinoma [ Time Frame: up to one month ]
    Investigators will directly compare pancreatic images from Fluorodopa F 18 PET combined with Computed Tomography versus the gold-standard of histopathological findings at surgery in subjects who received a partial or complete pancreatectomy

  2. Ratio of Standard Uptake Value max to sub max [ Time Frame: up to one month ]
    Investigators will compare SUV max to SUV sub max at a ratio of the current 1.5, a suggested 1.3 and by using visual inspection of the images.



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

Inclusion Criteria:

  • Patients with HI attending the Cook Children's Congenital Hyperinsulinism Center and being treated by an Endocrinologist which may be the PI or a partner of this clinician.
  • The 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. Failure of medical therapy is defined as both:

    • Hypoglycemia (blood glucose <70 m/dL) on a single measure despite the use of anti-hypoglycemic medications, if applicable to the individual patient, including and limited to diazoxide or octreotide
    • Inability to fast, defined as the inability to maintain a blood glucose >50 mg/dL for: 1) more than 12 hours for infants < 1 year of age; 2) more than 15 hours 1-3 years of age; 3) more than 18 hours over 3 years of age
  • Patients in whom the genetic testing (if available and informative) does not prove diffuse HI disease. Such children might be considered if they have one or more of the following situations:

    • no genetic testing results (e.g., due to insurance denial or parental refusal)
    • negative genetic testing (note: only 75% of mutations may be found with existing technology)
    • no autosomal recessive mutations in ABCC8 or KCNJ11 on the maternal allele
    • no autosomal dominant mutations in ABCC8 or KCNJ11
  • Patients thought to have focal HI disease based on genetic testing or insulinoma based on clinical evaluation and have well-controlled blood glucose levels with any degree of dietary or medical management, BUT the patient and their parent(s) or LAR wishes to proceed with surgery for a possible cure of HI disease.

Exclusion Criteria:

  • Patients who do not have a diagnosis of HI
  • Patients with genetic evidence of diffuse HI
  • Patients who are pregnant
  • Nursing mothers who are unwilling to discontinue breastfeeding their infant for 48 hours after Fluorodopa F 18 injection
  • Patients with a known allergy to Fluorodopa F 18 agent

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): NCT02021604


Contacts
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Contact: Larry Rodriguez, CRC 682-885-7208 Larry.Rodriguez@cookchildrens.org

Locations
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United States, Texas
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Principal Investigator: Paul Thornton, MD         
Sponsors and Collaborators
Cook Children's Health Care System
Investigators
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Principal Investigator: Paul Thornton, MD Cook Children's Health Care System

Additional Information:
Publications:
Thornton PS, Finegold DN, Stanley CA, Sperling MA. Hypoglycemia in the infant and child. In Sperling MA ed. Pediatric Endocrinology 2nd ed., pp 367-84. Philadelphia: Saunders, 2002.
Stanley CA, Thornton PS, Finegold DN, Sperling MA: Hypoglycemia in neonates and infants. In Sperling MA ed. Pediatric Endocrinology 2nd edition chpt 7 pages 135-59. 2002.

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Responsible Party: Cook Children's Health Care System
ClinicalTrials.gov Identifier: NCT02021604     History of Changes
Other Study ID Numbers: 2012-060
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cook Children's Health Care System:
Congenital Hyperinsulinism
HI
Hypoglycemia
FDOPA
18F-DOPA
Hyperinsulinism
Insulinoma

Additional relevant MeSH terms:
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Hyperinsulinism
Congenital Hyperinsulinism
Insulinoma
Glucose Metabolism Disorders
Metabolic Diseases
Adenoma, Islet Cell
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Infant, Newborn, Diseases
Hypoglycemia
Dihydroxyphenylalanine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs