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

Sponsor
Stanford University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02995642
Collaborator
(none)
0
1
1
14
0

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Targeted PET/CT and PET/MRI Imaging of Vascular Inflammation
Anticipated Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

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

    Primary Outcome Measures

    1. SUVmax of 18F-FPPRGD2 uptake by lesions (carotid atherosclerotic plaque or AAA). [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 [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.

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Michael V. McConnell, MD, MSEE, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Andrei Iagaru, Associate Professor of Radiology (Nuclear Medicine) at the Stanford University Medical Center, Stanford University
    ClinicalTrials.gov Identifier:
    NCT02995642
    Other Study ID Numbers:
    • 26885
    First Posted:
    Dec 16, 2016
    Last Update Posted:
    May 21, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    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, Associate Professor of Radiology (Nuclear Medicine) at the Stanford University Medical Center, Stanford University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 21, 2021