This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CANF-Comb-II PET-MR in Atherosclerosis Multisite

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05838547
Recruitment Status : Recruiting
First Posted : May 1, 2023
Last Update Posted : May 1, 2023
Sponsor:
Collaborators:
Cedars-Sinai Medical Center
University of California, Santa Barbara
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Pamela Woodard, MD, Washington University School of Medicine

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The goal of this observational study is to learn more about plaque biology in asymptomatic carotid artery stenosis (ACAS) patients through imaging. The main questions it aims to answer are:

  • To determine the ability of 64Cu-CANF-Comb positron emission tomography (PET) to risk stratify ACAS patients for stroke event, to include transient ischemic attack or remote ipsilateral intervention.
  • To further understand the role of Natriuretic Peptide Receptor C (NPRC) in the evolution of carotid atherosclerosis.

Participants will be asked to undergo a carotid PET-magnetic resonance imaging (MRI) examination to assess whether the carotid atherosclerosis uptake of 64Cu-CANF-Comb as measured by PET-MRI correlates with patient outcomes (stroke, transient ischemic attack, or remote ipsilateral intervention).


Condition or disease Intervention/treatment
Carotid Atherosclerosis Asymptomatic Carotid Artery Stenosis Carotid Artery Atheroma Drug: 64Cu-25%-CANF-Comb

Detailed Description:

This is an NIH-funded, Phase II, multicenter, open-label patient outcomes imaging study . Patients will undergo carotid PET/MRI after intravenous injection of 4-6 milliCuries (mCi) of the FDA Exploratory Investigational New Drug (eIND)-approved nanoparticle PET radiotracer (64Cu-C-type atrial natriuretic factor (CANF)-Comb). 80 subjects will be asymptomatic carotid artery stenosis (ACAS) patients with known carotid artery atherosclerosis by ultrasound/Doppler ≥ 60% diameter stenosis. These patients will be asked to undergo a carotid PET/MRI at a single time point 12-18 hours after intravenous injection of the 64Cu-CANF-Comb radiotracer.

Based on these promising results the investigators have devised an imaging protocol to determine the ability of 64Cu-25%-CANF-Comb PET to risk stratify ACAS patients treated with optimal medical therapy (OMT) alone with respect to patient outcomes. In this observational study, 80 patients with ACAS ≥ 60% will undergo 64Cu-25%-CANF-Comb PET/MRI. Patients will be maintained on either OMT alone or receive OMT and carotid endarterectomy (CEA) as determined by their treating vascular surgeon prior to imaging.

A total of 80 subjects, both men and women (≥18 years of age), will be recruited at Washington University (WU) and Cedars Sinai, with approximately 59 patients recruited at WU and approximately 21 patients recruited at Cedars Sinai. Patients will be asked to undergo carotid PET/MRI after intravenous injection of 64Cu-25%-CANF-Comb. These 80 subjects will be asymptomatic carotid artery stenosis (ACAS) patients with known carotid artery atherosclerosis by ultrasound/Doppler ≥ 60% diameter stenosis. These patients will be asked to undergo a carotid PET/MRI at a single time point 12-18 hours after intravenous injection of the 64Cu-25%-CANF-Comb radiotracer. Patients treated with OMT alone will undergo repeat PET/MRI at 12-18 months, or earlier if they develop symptoms. PET/MRI changes over the 12-18-month interval will be used to further understand the biology of carotid plaque evolution after treatment with OMT.

At the time of imaging, the investigators will record baseline medications to include any antiplatelet, statin, anti-hypertension, and diabetes medications (OMT), and basic risk factors and demographic information (e.g. diabetic, hypertensive, smoker, hypercholesterolemia), in addition to the patient's age and sex. Vital signs, a blood draw, and urinalysis will be obtained at baseline and at time of imaging (12-18 hrs after injection). A physical examination will be obtained at baseline and at the time of imaging. Telephone follow-up will occur within 48-72 hours (2-3 days) after discharge and then every 3 months until the end of the study to assess for ipsilateral ischemic cerebrovascular event (TIA, stroke) or remote ipsilateral carotid intervention. This outcomes data will be used to answer the primary objective of this project.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With Cu[64]-25%-CANF-Comb-II
Actual Study Start Date : March 21, 2023
Estimated Primary Completion Date : May 31, 2027
Estimated Study Completion Date : May 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Patients treated with Optimal Medical Therapy (OMT) alone.
Asymptomatic carotid artery stenosis (ACAS) patients with known carotid artery atherosclerosis by ultrasound/Doppler ≥ 60% diameter stenosis who are clinically referred for OMT alone.
 Drug: 64Cu-25%-CANF-Comb
Patients treated with OMT alone that are not treated with CEA will receive an intravenous injection of 4-6 mCi of 64Cu-25%-CANF-Comb radiotracer for PET/MR imaging at the initial imaging visit and at 18 months.
Patients treated with OMT and carotid endarterectomy (CEA).
Asymptomatic carotid artery stenosis (ACAS) patients with known carotid artery atherosclerosis by ultrasound/Doppler ≥ 60% diameter stenosis who are clinically referred for OMT and CEA.
 Drug: 64Cu-25%-CANF-Comb
Patients treated with OMT and CEA will receive an intravenous injection of 4-6 mCi of 64Cu-25%-CANF-Comb radiotracer for PET/MR imaging at the initial imaging visit.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of patients reporting ipsilateral ischemic cerebrovascular (TIA, stroke) or remote ipsilateral carotid intervention [ Time Frame: Through study completion, up to 4 years. ]
    Patients will be contacted every 3 months after PET/MR imaging to assess for interval ipsilateral ischemic cerebrovascular event. In patients treated with OMT, it is anticipated that higher 64Cu-CANF-Comb PET signal (SUV) will correlate with increased ipsilateral ischemic cerebrovascular event (TIA, stroke) or remote ipsilateral carotid intervention (CEA surgery or stent placement); PET signal (SUV) will be assessed as a marker of risk for event in comparison to anatomic features of vulnerable plaque on MRI, with the goal of determining 64Cu-CANF-Comb PET signal above which suggests ACAS at higher risk.


Secondary Outcome Measures :
  1. Changes in 64Cu-CANF-Comb PET signal - OMT [ Time Frame: 18 months. ]
    Patients treated with OMT will be imaged at baseline and at 18 months to determine interval change in 64Cu-CANF-Comb PET signal (SUV) over time.

  2. PET signal relative to presence of targeted receptor, NPR-C and histopathological features of plaque vulnerability - CEA surgery as Treatment [ Time Frame: Immediately after surgery. ]
    In patients who initially undergo CEA, PET signal (SUV) will be compared to ex vivo plaque vulnerability and NPRC cellular distribution to facilitate understanding of gene expression using immunohistochemistry (IHC) and cell lineage/origin through single cell RNA (scRNA)/cellular indexing of transcriptomes and epitopes (CITE)-seq.


Biospecimen Retention:   Samples Without DNA
Carotid plaque tissue specimens will be collected at the time of surgery.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals ≥18 years of age with asymptomatic carotid artery stenosis.
Criteria

Inclusion Criteria:

  • Adults, 18 years of age or older
  • Patients who have undergone carotid Doppler/ultrasound imaging which have demonstrated a ≥ 60% diameter carotid artery stenosis.
  • The treating surgeon has planned either treatment with optimal medical therapy (OMT) alone, or OMT and carotid endarterectomy (CEA) surgical intervention.

Exclusion Criteria:

  • Inability to receive and sign informed consent.
  • Patients with an unstable clinical condition that in the opinion of the Sponsor.
  • Investigator or designee precludes participation in the study.
  • Inability to tolerate up to 60 minutes in a supine position with arms down at sides for PET-MR imaging.
  • Prior history of CEA or carotid artery stent procedure.
  • Past medical history of TIA or stroke within the last 6 months.
  • Unwilling to comply with study procedures and/or unable to be available for the duration of the study outlined in the protocol.
  • Contraindications to MR imaging (pacemaker, brain aneurysm clips, shrapnel, claustrophobia, etc.).
  • Currently pregnant or lactating. All female subjects of childbearing potential must have a documented negative pregnancy test (serum or urine hCG) performed within 24 hours immediately prior to the administration of 64Cu-25%-CANF-Comb or documented post- menopausal defined as the cessation of menses for ≥ 12 months or documentation of having a bilateral oophorectomy and/or hysterectomy.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05838547


Contacts
Layout table for location contacts
Contact: Molly Mohrman 314-747-4633 mohrmanm@wustl.edu
Contact: Pamela Woodard, MD 314-747-3386 woodardp@wustl.edu

Locations
Layout table for location information
United States, California
Cedars Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Yibin Xie, Ph.D       Yibin.Xie@cshs.org   
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63130-2344
Contact: Pamela K Woodard, MD       woodardp@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Cedars-Sinai Medical Center
University of California, Santa Barbara
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Pamela Woodard, MD Washington University School of Medicine
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Pamela Woodard, MD, HM Wilson Professor of Radiology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT05838547    
Other Study ID Numbers: 202210116
123,617 ( Other Identifier: Food and Drug Administration (FDA) eIND Number )
R01HL159803 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2023    Key Record Dates
Last Update Posted: May 1, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pamela Woodard, MD, Washington University School of Medicine:
Stroke
TIA
Vascular Disease
Cardiovascular Disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Carotid Stenosis
Carotid Artery Diseases
Atherosclerosis
Plaque, Atherosclerotic
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathological Conditions, Anatomical