Ignite Creation Date:
2024-05-06 @ 9:29 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02995642
Status:
WITHDRAWN
Last Update Posted:
2021-05-21
First Post:
2016-12-14
Brief Title:
Targeted PETCT and PETMRI Imaging of Vascular Inflammation
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Targeted PETCT and PETMRI Imaging of Vascular Inflammation
Status:
WITHDRAWN
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Resources not secured
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Stroke and abdominal aortic aneurysms AAAs are common and highly lethal vascular diseases Angiogenesis and infiltration of inflammatory cells such as macrophages may cause stroke and AAAs
The purpose of this study is to test PETCT and PETMRI imaging to specifically detect those diseases using a new developed agent 18F-FPPRGD2 that can target angiogenesis and macrophages
The purpose of this study is to test PETCT and PETMRI imaging to specifically detect those diseases using a new developed agent 18F-FPPRGD2 that can target angiogenesis and macrophages
Detailed Description:
20 subjects with either carotid bifurcation stenosis of 50 by ultrasound on at least one side 10 patients or advanced AAAs 10 patients and surgical intervention planned will be identified from physicians from the Division of Vascular Surgery at Stanford
Either a PETCT or a PETMRI will be performed for each subject
PETCT scans will be performed in 3D mode using GE Discovery 600 or GE Discovery 690 scanners GE Healthcare
PETMRI scans will be performed using the novel PETMRI system at Stanford including a sensitive PET time-of-flight TOF scanner with an advanced 3T MRI scanner
The study patients will receive an intravenous administration of 10mCi of the prescribed radiotracer 18F-FPPRGD2 PETCT or PETMRI images will be obtained starting 45-60 minutes after radiotracer administration For PETCT each image acquisition will begin with a non-contrast CT scan obtained from the vertex through the mid-thighs of the subjects For PETMRI non-contrast images of the carotid or aorta will be performed PET imaging will follow Patients vital signs will be monitored during the procedure and a physician will be available if there is need for immediate medical attention The PET images will be reconstructed with a standard iterative algorithm using GE software release 50
After the planned surgery we will also assess the histopathological correlation between the disease lesions and PETCT or PETMRI imaging characteristics
Either a PETCT or a PETMRI will be performed for each subject
PETCT scans will be performed in 3D mode using GE Discovery 600 or GE Discovery 690 scanners GE Healthcare
PETMRI scans will be performed using the novel PETMRI system at Stanford including a sensitive PET time-of-flight TOF scanner with an advanced 3T MRI scanner
The study patients will receive an intravenous administration of 10mCi of the prescribed radiotracer 18F-FPPRGD2 PETCT or PETMRI images will be obtained starting 45-60 minutes after radiotracer administration For PETCT each image acquisition will begin with a non-contrast CT scan obtained from the vertex through the mid-thighs of the subjects For PETMRI non-contrast images of the carotid or aorta will be performed PET imaging will follow Patients vital signs will be monitored during the procedure and a physician will be available if there is need for immediate medical attention The PET images will be reconstructed with a standard iterative algorithm using GE software release 50
After the planned surgery we will also assess the histopathological correlation between the disease lesions and PETCT or PETMRI imaging characteristics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None