Expired Study
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Houston, Texas 77030


Purpose:

The primary objective of this study is to evaluate the utility of [18F]-DOPA PET to provide improved presurgical planning and distinguish between focal and diffuse forms of HI. The investigators will perform descriptive analysis, relying on visual analysis to diagnose and localize a focal lesion. Our findings will be compared to surgical histopathology to determine sensitivity and specificity or this technique. The investigators will also track patient surgical outcomes, specifically whether the patient is surgically "cured" or still requires medical management to control residual hypoglycemia.


Study summary:

Hyperinsulinemic hypoglycemia is caused by low glucose due to excessive insulin secretion and remains difficult to treat because of the requirement for extensive amounts of glucose and the lack of effective long-term medical therapy. Correct diagnosis, localization, and limited excision of the focal lesion will result in a complete cure of the patient. In contrast, medically unresponsive diffuse disease requires a near total pancreatectomy, greatly increasing the risk of future diabetes mellitus. Fortunately, [18F]-DOPA PET has been shown to be a useful noninvasive imaging method for distinguishing between focal and diffuse forms of hyperinsulinemic hypoglycemia. In this study, the investigators seek to validate the effectiveness of using PET/MR and PET/CT with F-DOPA to accurately and reliably detect and localize disease.


Criteria:

Inclusion Criteria: - All Patients clinically diagnosed with Hyperinsulinemia of any age - Patients in need of PET scan - Patients that require sedation - Patients that do not require sedation Exclusion Criteria: Subjects presenting with any of the following will not be included in the study: - Patients without Hyperinsulinemia - Patients who are or may be pregnant - Serious intercurrent medical illness other than hypoglycemia that precludes having the scan either because of patient instability or concerns about potential toxicity. - Patient's requiring emergency surgical intervention that would be inappropriately delayed by [18F]-DOPA PET imaging.


Study is Available At:


Original ID:

H-32432


NCT ID:

NCT02533219


Secondary ID:


Study Acronym:

[18F]-DOPA


Brief Title:

Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia


Official Title:

Phase II Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia


Overall Status:

Available


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

64 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Baylor College of Medicine


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Expanded Access


Study Design:

N/A


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Primary Contact:Victor Seghers, PhD, MD
832-822-0429
vjsegher@texaschildrens.org

Study Dates

Verification Date:October 2016
Last Changed Date:October 10, 2016
First Received Date:August 24, 2015

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:18 F-DOPA
Description:Subjects will undergo PET imaging with [18F]-DOPA. All PET imaging will be performed after administration of a single dose (0.08 - 0.16 mCurie/kg) of [18F]-DOPA. PET imaging can be performed on either Philips Ingenuity TF PET/MRI or PET/CT.
Other Name:Fluorine-18-L-dihydroxyphenylalanine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Baylor College of Medicine
Agency Class:Other
Agency Type:Collaborator
Agency Name:Texas Children's Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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