Targeted PET/CT and PET/MRI Imaging of Vascular Inflammation

Stanford University

Status and phase: Withdrawn; Phase 2

Conditions: Carotid Atherosclerosis; Aortic Aneurysm, Abdominal

Treatments: Procedure: Computed tomography; Device: Positron emission tomography; Device: Magnetic Resonance Imaging; Drug: 18F-FPPRGD2

Study type: Interventional

Funder types: Other

Identifiers

NCT02995642

26885

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

18F-FPPRGD2

Experimental group

Description:

Subjects (with either carotid atherosclerosis stenosis or AAA) will receive a single intravenous injection of 10mCi of 18F-FPPRGD2 and will undergo positron emission tomography/computed tomography (PET/CT) or PET/MRI (PET/magnetic resonance imaging) imaging 45-60 minutes after injection.

Treatment:

Drug: 18F-FPPRGD2

Device: Magnetic Resonance Imaging

Device: Positron emission tomography

Procedure: Computed tomography