Clinical trial NCT02995642: Targeted PET/CT and PET/MRI Imaging of Vascular Inflammation
Official title: Targeted PET/CT and PET/MRI Imaging of Vascular Inflammation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Aortic Aneurysm, Abdominal
Carotid Atherosclerosis
Keywords: Aortic Aneurysm, Abdominal
Carotid Stenosis
Atherosclerosis
Angiogenesis
Inflammation
Macrophages
Positron-Emission Tomography
Computerized tomography
Magnetic Resonance Imaging
(18F)FPP(RGD)2
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 PET/CT and PET/MRI 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 PET/CT or a PET/MRI will be performed for each subject:

* PET/CT scans will be performed in 3D mode using GE Discovery 600 or GE Discovery 690 scanners (GE Healthcare).
* PET/MRI scans will be performed using the novel PET/MRI 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). PET/CT or PET/MRI images will be obtained starting 45-60 minutes after radiotracer administration. For PET/CT, each image acquisition will begin with a non-contrast CT scan obtained from the vertex through the mid-thighs of the subjects. For PET/MRI, non-contrast images of the carotid or aorta will be performed. PET imaging will follow. Patient's 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 5.0.

After the planned surgery, we will also assess the histopathological correlation between the disease lesions and PET/CT or PET/MRI imaging characteristics.

Eligibility criteria: Inclusion Criteria:

* Greater than 18 year-old at the time of radiotracer administration
* Provides written informed consent
* Patients diagnosed with either carotid artery stenosis or abdominal aortic aneurysms (AAAs) as identified in Vascular Surgery, in whom a surgical procedure is scheduled
* Able to remain still for duration of an imaging procedure (about one hour).

Exclusion Criteria:

* Less than 18 year-old at the time of radiotracer administration
* Unable to provide written informed consent
* Pregnant women
* Prior carotid or abdominal surgery
* History of radiation therapy to the neck and abdomen
* MRI contraindications (including ferromagnetic objects or devices).

Primary outcomes:
measure: SUVmax of 18F-FPPRGD2 uptake by lesions (carotid atherosclerotic plaque or AAA).
timeFrame: Up to 60 minutes post-injection (at time of scan)
measure: Percent agreement of 18F-FPPRGD2 PET with pathology
timeFrame: Up to 60 minutes post-injection (at time of scan)
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Michael V. McConnell, MD, MSEE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mittra ES, Goris ML, Iagaru AH, Kardan A, Burton L, Berganos R, Chang E, Liu S, Shen B, Chin FT, Chen X, Gambhir SS. Pilot pharmacokinetic and dosimetric studies of (18)F-FPPRGD2: a PET radiopharmaceutical agent for imaging alpha(v)beta(3) integrin levels. Radiology. 2011 Jul;260(1):182-91. doi: 10.1148/radiol.11101139. Epub 2011 Apr 18.
citation: Kitagawa T, Kosuge H, Chang E, James ML, Yamamoto T, Shen B, Chin FT, Gambhir SS, Dalman RL, McConnell MV. Integrin-targeted molecular imaging of experimental abdominal aortic aneurysms by (18)F-labeled Arg-Gly-Asp positron-emission tomography. Circ Cardiovasc Imaging. 2013 Nov;6(6):950-6. doi: 10.1161/CIRCIMAGING.113.000234. Epub 2013 Aug 30.