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NCT00005111 · ClinicalTrials.gov registry record

PET Scans in Normal Volunteers and Patients With Fabry Disease

A clinical trial of Healthy and Fabry Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Completed
Registry status
24
Enrollment target
1
Study location

NCT00005111 is a study of Healthy and Fabry Disease that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 24 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00005111, a study of Healthy and Fabry Disease, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

COMPLETED
Registry status
24 participants
Enrollment target
1
Study location

Study Summary

This study will determine the rate of sugar metabolism in the brain of patients with Fabry disease, a genetic disease of abnormal lipid metabolism. Compared with healthy people, patients with Fabry disease have increased blood flow to the brain, which may result from abnormal brain metabolic activity. This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI) to compare brain sugar metabolism in eight untreated patients, eight patients who are receiving enzyme replacement therapy, and eight healthy volunteers. Patients with treated and untreated Fabry disease and normal volunteers may be eligible for this study. Participants will undergo the following two procedures: 1. PET scan \< The patient lies in the PET scanning machine. First, the chest is scanned for a few minutes to determine how much radiation the tissues of the chest absorb. A radioactive sugar called fluorodeoxyglucose (FDG) is then injected through a catheter (thin plastic tube placed in a vein) and the heart is scanned for about 45 minutes to measure the amount of FDG in the blood inside the heart. The head is then scanned for about 20 minutes to measure FDG in the brain. This measurement tells how much sugar the brain uses for energy. The procedure requires insertion of two or three catheters. A special facemask may be molded to the patient's head to help hold the head still during the scanning. 2. MRI scan \< The patient lies on a table surrounded by the scanner (a metal cylinder) for about 60 minutes. A strong magnetic field and radio waves are used to show images of structural and chemical changes in tissues. This study may provide information that will help explain abnormalities in Fabry disease and the effect of treatment on the brain.

Conditions Studied

Study Locations (1)

Maryland

  • National Institute of Neurological Disorders and Stroke (NINDS) - Bethesda

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2000-04
Est. Completion 2001-03

What the Registry Record Tells You About NCT00005111

The ClinicalTrials.gov registry entry for NCT00005111 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 0 interventions.

NCT00005111 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00005111 about?

NCT00005111 is a clinical study titled "PET Scans in Normal Volunteers and Patients With Fabry Disease". This study will determine the rate of sugar metabolism in the brain of patients with Fabry disease, a genetic disease of abnormal lipid metabolism. Compared with healthy people, patients with Fabry disease have increased blood flow to the brain, which may result from abnormal brain metabolic activit...

What is the current status of trial NCT00005111?

This trial is currently completed. The enrollment target is 24 participants. The study started on 2000-04. Estimated completion is 2001-03.

What conditions does trial NCT00005111 study?

This clinical trial studies the following conditions: Healthy, Fabry Disease.

Who is sponsoring clinical trial NCT00005111?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00005111 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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