Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083629
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-05-27
Brief Title:
Use of 18FFECNT in Positron Emission Tomography
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
PET Whole Body Biodistribution and Test Retest Brain Imaging Studies Using a Dopamine Transporter Ligand 18FFECNT
Status:
COMPLETED
Status Verified Date:
2005-09
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 examine the use of a new radioactive tracer called 18FFECNT in positron emission tomography PET scanning for measuring dopamine transporter DAT in the brain DAT is found in brain neurons nerve cells that release the chemical messenger dopamine By taking pictures of the DAT scientists hope to learn more about the function of these neurons
Normal healthy volunteers between 18 and 65 years of age may be eligible for this study Candidates are screened with a medical history and physical examination psychological assessment and blood and urine tests
Subjects enrolled in the study participate in one of the following procedures
Brain Imaging Study Part 1
Two catheters small plastic tubes are placed into veins in the subjects arms for injecting 18FFECNT and for collecting blood samples during the scan A third catheter is placed into a wrist artery to obtain arterial blood during the scan With the catheters in place the subject lies down on the scanner bed with his or her head placed in a special mask that limits movement during the brain scan The scan begins with an initial x-ray like picture for about 10 minutes after which the 18FFECNT is injected and the actual PET scan starts The entire procedure takes about 6 hours including 2 hours of continuous scanning sessions during which the subject is required to lie still Subjects can relax out of the scanner between scans They are monitored throughout the procedure Vital signs are measured and electrocardiogram is taken once before and twice after injection of the tracer At the end of the scanning additional blood and urine samples are collected Subjects are asked to urinate every 2 hours to lessen the radioactivity in the body
Whole Body Imaging Study Part 2
For this procedure a catheter is placed in a vein for injecting the 18FFECNT tracer A total of five scans are taken each one spanning from head to upper thigh During the course of the scans x-ray like pictures are obtained The first scan takes about 100 minutes Four additional 1-hour scans are done every 100 minutes The total time for the scans is about 6 hours and the total time for the entire procedure is about 9 hours About 2 tablespoons of blood are drawn by needle stick at one time during the imaging Subjects can leave the PET scanner between scans They are asked to urinate every 2 hours for 6 hours from the time of tracer injection and to collect all the urine so that radioactivity can be measured
Brain Imaging Study Part 3
Part 3 of the study is the same as Part 1 except that two PET procedures are done on separate days the second within 4 weeks of the first In addition participants may also under magnetic resonance imaging MRI scanning a test that uses magnetic fields and radio waves to obtain pictures of the brain
Normal healthy volunteers between 18 and 65 years of age may be eligible for this study Candidates are screened with a medical history and physical examination psychological assessment and blood and urine tests
Subjects enrolled in the study participate in one of the following procedures
Brain Imaging Study Part 1
Two catheters small plastic tubes are placed into veins in the subjects arms for injecting 18FFECNT and for collecting blood samples during the scan A third catheter is placed into a wrist artery to obtain arterial blood during the scan With the catheters in place the subject lies down on the scanner bed with his or her head placed in a special mask that limits movement during the brain scan The scan begins with an initial x-ray like picture for about 10 minutes after which the 18FFECNT is injected and the actual PET scan starts The entire procedure takes about 6 hours including 2 hours of continuous scanning sessions during which the subject is required to lie still Subjects can relax out of the scanner between scans They are monitored throughout the procedure Vital signs are measured and electrocardiogram is taken once before and twice after injection of the tracer At the end of the scanning additional blood and urine samples are collected Subjects are asked to urinate every 2 hours to lessen the radioactivity in the body
Whole Body Imaging Study Part 2
For this procedure a catheter is placed in a vein for injecting the 18FFECNT tracer A total of five scans are taken each one spanning from head to upper thigh During the course of the scans x-ray like pictures are obtained The first scan takes about 100 minutes Four additional 1-hour scans are done every 100 minutes The total time for the scans is about 6 hours and the total time for the entire procedure is about 9 hours About 2 tablespoons of blood are drawn by needle stick at one time during the imaging Subjects can leave the PET scanner between scans They are asked to urinate every 2 hours for 6 hours from the time of tracer injection and to collect all the urine so that radioactivity can be measured
Brain Imaging Study Part 3
Part 3 of the study is the same as Part 1 except that two PET procedures are done on separate days the second within 4 weeks of the first In addition participants may also under magnetic resonance imaging MRI scanning a test that uses magnetic fields and radio waves to obtain pictures of the brain
Detailed Description:
The dopamine system plays important roles in various neurological and psychiatric disorders such as Parkinsons disease schizophrenia mood disorders and attention-deficit hyperactivity disorder Several positron emission tomography PET and single photon emission computed topography SPECT tracers have been developed including 11CCFT and 123Ibeta-CIT These tracers have been successfully applied in patients particularly to stage those with Parkinsons disease However these tracers lack selectivity among monoamine dopamine serotonin and norepinephrine transporters Recently a new PET tracer 18FFECNT brain uptake and washout has been developed which has high selectivity and affinity to the dopamine transporter DAT Part 1 of this study will measure the kinetics of 18FFECNT brain uptake and washout Part 2 will estimate radiation-absorbed doses in healthy human subjects by performing whole body PET imaging studies Part 3 will assess the reliability of measuring DAT densities in the brain by performing a test retest brain PET studies in healthy human subjects The results of this overall study are required to apply this tracer in various neurological and psychiatric disorders in the future
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 |
|---|---|---|---|
| 04-M-0204 | None | None | None |