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

NCT ID: NCT02995642

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2020-12-31

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.

Conditions

Aortic Aneurysm, Abdominal; Carotid Atherosclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

18F-FPPRGD2

Intervention Type: DRUG

One single intravenous injection.

Positron emission tomography

Intervention Type: DEVICE

Undergo 18F-FPPRGD2 PET/CT or PET/MRI

Computed tomography

Intervention Type: PROCEDURE

Undergo 18F-FPPRGD2 PET/CT or PET/MRI

Magnetic Resonance Imaging

Intervention Type: DEVICE

Undergo 18F-FPPRGD2 PET/CT or PET/MRI

Interventions

18F-FPPRGD2

One single intravenous injection.

Intervention Type: DRUG

Positron emission tomography

Undergo 18F-FPPRGD2 PET/CT or PET/MRI

Intervention Type: DEVICE

Computed tomography

Undergo 18F-FPPRGD2 PET/CT or PET/MRI

Intervention Type: PROCEDURE

Magnetic Resonance Imaging

Undergo 18F-FPPRGD2 PET/CT or PET/MRI

Intervention Type: DEVICE

Other Intervention Names

Fluorine-18-labeled RGD peptide [18F] FPA-PEG3-E[c(RGDyK)]2; PET; PET scan; tomography, emission computed; tomography, computed; MRI; NMR imaging; NMRI; nuclear magnetic resonance imaging

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Andrei Iagaru

Associate Professor of Radiology (Nuclear Medicine) at the Stanford University Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael V. McConnell, MD, MSEE

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21502381 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23995363 (View on PubMed)

Other Identifiers

26885

Identifier Type: -

Identifier Source: org_study_id