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18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia

Primary Purpose

Congenital Hyperinsulinism, Beckwith-Wiedemann Syndrome, Insulinoma

Status

Available

Phase

Locations

United States

Study Type

Expanded Access

Intervention

18F-DOPA

About this trial

This is an expanded access trial for Congenital Hyperinsulinism focused on measuring Hypoglycemia, Hyperinsulinism

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

Subjects of any age with hyperinsulinemic hypoglycemia, diagnosed by a fasting test and/or response to glucagon stimulation.
Subjects who are eligible for pancreatic surgery regardless of prior pancreatic surgery

Exclusion Criteria:

Pregnant or lactating females
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
Subjects who are not a candidate for pancreatic surgery

Sites / Locations

Children's Hospital of Philadelphia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01916148

First Posted

July 30, 2013

Last Updated

April 5, 2023

Sponsor

Children's Hospital of Philadelphia

1. Study Identification

Unique Protocol Identification Number

NCT01916148

Brief Title

18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia

Official Title

Expanded Access Use of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia

Study Type

Expanded Access

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Available

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Children's Hospital of Philadelphia

4. Oversight

5. Study Description

Brief Summary

This purpose of this study is to determine the ability of an 18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET scan to detect a focal lesion of hyperinsulinism and determine the location in patients with congenital hyperinsulinism, Beckwith Wiedemann Syndrome and suspected insulinoma. Safety data will be collected.

Detailed Description

Patients with hyperinsulinemic hypoglycemia are at risk for neurological damage due to hypoglycemia. Early surgical intervention can be preventative. F-DOPA PET may be able to detect of a focal lesion prior to surgical intervention and be used during surgical planning to guide the surgical procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Hyperinsulinism, Beckwith-Wiedemann Syndrome, Insulinoma

Keywords

Hypoglycemia, Hyperinsulinism

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

18F-DOPA

Intervention Description

18F-DOPA is a PET scan radiotracer.

10. Eligibility

Sex

All

Eligibility Criteria

Inclusion Criteria: Subjects of any age with hyperinsulinemic hypoglycemia, diagnosed by a fasting test and/or response to glucagon stimulation. Subjects who are eligible for pancreatic surgery regardless of prior pancreatic surgery Exclusion Criteria: Pregnant or lactating females 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 Subjects who are not a candidate for pancreatic surgery

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Susan Becker, RN, BSN, CCRC

Phone

267-426-0269

Beckers@chop.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Lisa States, MD

Phone

267-425-7146

States@chop.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa States, MD

Organizational Affiliation

Children's Hospital of Philadelphia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Available

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lisa States, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

34230074

Citation

States LJ, Davis JC, Hamel SM, Becker SA, Zhuang H. 18F-6-Fluoro-l-Dopa PET/CT Imaging of Congenital Hyperinsulinism. J Nucl Med. 2021 Jul;62(Suppl 2):51S-56S. doi: 10.2967/jnumed.120.246033.

Results Reference

derived

Learn more about this trial

18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia

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