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

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ClinicalTrials.gov Identifier: NCT02995642
Recruitment Status : Not yet recruiting
First Posted : December 16, 2016
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

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.


Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Abdominal Carotid Atherosclerosis Drug: 18F-FPPRGD2 Device: Positron emission tomography Procedure: Computed tomography Device: Magnetic Resonance Imaging Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Targeted PET/CT and PET/MRI Imaging of Vascular Inflammation
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18F-FPPRGD2
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.
Drug: 18F-FPPRGD2
One single intravenous injection.
Other Name: Fluorine-18-labeled RGD peptide [18F] FPA-PEG3-E[c(RGDyK)]2

Device: Positron emission tomography
Undergo 18F-FPPRGD2 PET/CT or PET/MRI
Other Names:
  • PET
  • PET scan
  • tomography, emission computed

Procedure: Computed tomography
Undergo 18F-FPPRGD2 PET/CT or PET/MRI
Other Name: tomography, computed

Device: Magnetic Resonance Imaging
Undergo 18F-FPPRGD2 PET/CT or PET/MRI
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging




Primary Outcome Measures :
  1. SUVmax of 18F-FPPRGD2 uptake by lesions (carotid atherosclerotic plaque or AAA). [ Time Frame: Up to 60 minutes post-injection (at time of scan) ]

    The arterial standardized uptake value (SUV) for carotid plaque or AAA will be calculated as the mean pixel activity within the region of interest (ROI).

    By averaging the SUV values for each artery slice, we will derived a mean SUV value for the entire artery (arterial SUV). This will be corrected for blood activity by division by the average blood SUV estimated from either the inferior vena cava or jugular vein to produce a blood-corrected artery SUV, known as the arterial tissue-to-background ratio (TBR).


  2. Percent agreement of 18F-FPPRGD2 PET with pathology [ Time Frame: Up to 60 minutes post-injection (at time of scan) ]
    After the planned surgical procedure, the accuracy of 18F-FPPRGD2 PET as percent agreement with pathology (including angiogenesis and inflammation assessment) will be calculated.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995642


Contacts
Contact: Michael V. McConnell, MD, MSEE (650) 723-6459 mcconnell@stanford.edu
Contact: Kat Gallagher, AA (650) 723-7476 kgallagher@stanford.edu

Locations
United States, California
Stanford University Not yet recruiting
Stanford, California, United States, 94305
Contact: Andrea Otte    650-736-4183    anotte@stanford.edu   
Contact: Lacey Greene, MS, CNMT    6507254712    lacey.greene@stanford.edu   
Principal Investigator: Guido Davidzon, MD         
Sub-Investigator: Andrei Iagaru, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Michael V. McConnell, MD, MSEE Stanford University

Publications:
Responsible Party: Andrei Iagaru, Associate Professor of Radiology (Nuclear Medicine) at the Stanford University Medical Center, Stanford University
ClinicalTrials.gov Identifier: NCT02995642     History of Changes
Other Study ID Numbers: 26885
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrei Iagaru, Stanford University:
Aortic Aneurysm, Abdominal
Carotid Stenosis
Atherosclerosis
Angiogenesis
Inflammation
Macrophages
Positron-Emission Tomography
Computerized tomography
Magnetic Resonance Imaging
(18F)FPP(RGD)2

Additional relevant MeSH terms:
Inflammation
Aneurysm
Atherosclerosis
Aortic Aneurysm
Carotid Artery Diseases
Aortic Aneurysm, Abdominal
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Aortic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases