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

NCT02995642 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 26885
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

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

  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).

  Up to 60 minutes post-injection (at time of scan)

• Percent agreement of 18F-FPPRGD2 PET with pathology

  After the planned surgical procedure, the accuracy of 18F-FPPRGD2 PET as percent agreement with pathology (including angiogenesis and inflammation assessment) will be calculated.

  Up to 60 minutes post-injection (at time of scan)

Study Arms (1)

18F-FPPRGD2

EXPERIMENTAL

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; Device: Positron emission tomography; Procedure: Computed tomography; Device: Magnetic Resonance Imaging

Interventions

18F-FPPRGD2 DRUG

One single intravenous injection.

Also known as: Fluorine-18-labeled RGD peptide [18F] FPA-PEG3-E[c(RGDyK)]2

18F-FPPRGD2

Positron emission tomography DEVICE

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

Also known as: PET, PET scan, tomography, emission computed

18F-FPPRGD2

Computed tomography PROCEDURE

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

Also known as: tomography, computed

18F-FPPRGD2

Magnetic Resonance Imaging DEVICE

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

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

18F-FPPRGD2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

• 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.

  PMID: 21502381 BACKGROUND

• 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.

  PMID: 23995363 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Carotid Artery Diseases; Carotid Stenosis; Atherosclerosis; Inflammation

Interventions

FPP(RGD)2; Positron-Emission Tomography; Tomography, Emission-Computed; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Arteriosclerosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Michael V. McConnell, MD, MSEE

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology (Nuclear Medicine) at the Stanford University Medical Center

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 16, 2016
• Study Start: October 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)