Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005111
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-04-13
Brief Title:
PET Scans in Normal Volunteers and Patients With Fabry Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
18Fluorodeoxyglucose Positron Emission Tomography in Patients With Fabry Disease
Status:
COMPLETED
Status Verified Date:
2000-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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
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 patients 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
Detailed Description:
We have found that patients with Fabry disease have an increased resting global cerebral blood flow compared with healthy subjects This augmentation may result from an abnormal metabolic activity in the brain of the patients The goal of this protocol is to study the cerebral metabolic rate of glucose rCMRGlu in eight untreated patients with Fabry disease eight Fabry patients who are receiving enzyme replacement therapy and compare it with the rCMRGlu eight in healthy volunteers In order to minimize the need for arterial lines we shall image the left ventricle of the heart to obtain the 18FDG time-activity curve needed to measure rCMRGlu The method will be validated in the healthy volunteers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-N-0106 | None | None | None |