Carotid AtherosclerosisNCT05838547
CANF-Comb-II PET-MR in Atherosclerosis Multisite
An observational study of Carotid Atherosclerosis and Asymptomatic Carotid Artery Stenosis, run by Washington University School of Medicine at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Atherosclerosis, Asymptomatic Carotid Artery Stenosis, Carotid Artery Atheroma
- What is being tested?
- 64Cu-25%-CANF-Comb
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Mar 2023to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals ≥18 years of age with asymptomatic carotid artery stenosis.
Who may be able to join
- Adults, 18 years of age or older
- Asymptomatic carotid artery stenosis patients who have undergone carotid Doppler/ultrasound imaging or other carotid 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.
Who cannot join
- 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 on the ipsilateral side.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Yibin Xie, Ph.D, Yibin.Xie@cshs.org
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63130-2344
Pamela K Woodard, MD, woodardp@wustl.edu
About this study
Official title: PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With Cu[64]-25%-CANF-Comb-II
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).
Read the 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 2-6 milliCuries (mCi) of the FDA Exploratory Investigational New Drug (eIND)-approved nanoparticle PET radiotracer (64Cu-C-type atrial natriuretic factor (CANF)-Comb). A total of 80 subjects will be recruited to this study. These subjects will be asymptomatic carotid artery stenosis (ACAS) patients with known carotid artery atherosclerosis by ultrasound/Doppler or other carotid imaging ≥ 60% diameter stenosis. These patients will be asked to undergo a carotid PET/MRI at a single time point 12-24 hours after intravenous injection of the 64Cu-CANF-Comb radiotracer.
Based on promising results from a proof of concept study, 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 or other carotid imaging ≥ 60% diameter stenosis. These patients will be asked to undergo a carotid PET/MRI at a single time point 12-24 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. While 12-18 months is the preferred window for repeat PET/MRI, if imaging during this time frame is not achievable, the patient may return anytime throughout the remainder of the study. PET/MRI changes over time 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 (12-24 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 (+/- 5 days) 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.
- Being tested
- 64Cu-25%-CANF-Comb
- Keywords
- Stroke, TIA, Vascular Disease, Cardiovascular Disease
- Medical subject headings
- Carotid Artery Diseases, Stroke, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-25%-CANF-CombDrug
Patients treated with OMT alone that are not treated with CEA will receive an intravenous injection of 2-6 mCi of 64Cu-25%-CANF-Comb radiotracer for PET/MR imaging at the initial imaging visit and at 12-18 months, or earlier if they develop symptoms. While 12-18 months is the preferred window for repeat imaging, if imaging during this time frame is not achievable, the patient may return anytime throughout the remainder of the study.
64Cu-25%-CANF-CombDrug
Patients treated with OMT and CEA will receive an intravenous injection of 2-6 mCi of 64Cu-25%-CANF-Comb radiotracer for PET/MR imaging at the initial imaging visit.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Optimal Medical Therapy (OMT) alone. | Asymptomatic carotid artery stenosis (ACAS) patients with known carotid artery atherosclerosis by ultrasound/Doppler or other carotid imaging ≥ 60% diameter stenosis who are clinically referred for OMT alone. Receives: Drug: 64Cu-25%-CANF-Comb | |
| Patients treated with OMT and carotid endarterectomy (CEA). | Asymptomatic carotid artery stenosis (ACAS) patients with known carotid artery atherosclerosis by ultrasound/Doppler or other carotid imaging ≥ 60% diameter stenosis who are clinically referred for OMT and CEA. Receives: Drug: 64Cu-25%-CANF-Comb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients reporting ipsilateral ischemic cerebrovascular event (TIA, stroke) or remote ipsilateral carotid intervention
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.
Measured: Through study completion, up to 4 years.
Secondary outcomes (2)
Changes in 64Cu-CANF-Comb PET signal - OMT
Patients treated with OMT will be imaged at baseline and at 12-18 months, or earlier if they develop symptoms, to determine interval change in 64Cu-CANF-Comb PET signal (SUV) over time. While 12-18 months is the preferred window for repeat imaging, if imaging during this time frame is not achievable, the patient may return anytime throughout the remainder of the study.
Measured: 12-18 months (preferred); through study completion, up to 4 years.
PET signal relative to presence of targeted receptor, NPR-C and histopathological features of plaque vulnerability - CEA surgery as Treatment
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.
Measured: Immediately after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start21 Mar 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center, University of California, Santa Barbara, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Pamela Woodard, MD, Washington University School of Medicine
- Investigators
- Pamela Woodard, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838547
- Sponsor's protocol ID
- 202210116
- Other IDs
- 123,617, R01HL159803
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2023
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With Cu[64]-25%-CANF-Comb-II
- ClinicalTrials.gov ID
- NCT05838547
- Acronym / sponsor ID
- 202210116
- Keywords
- Stroke, TIA, Vascular Disease, Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center, University of California, Santa Barbara, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 2-6 milliCuries (mCi) of the FDA Exploratory Investigational New Drug (eIND)-approved nanoparticle PET radiotracer (64Cu-C-type atrial natriuretic factor (CANF)-Comb). A total of 80 subjects will be recruited to this study. These subjects will be asymptomatic carotid artery stenosis (ACAS) patients with known carotid artery atherosclerosis by ultrasound/Doppler or other carotid imaging ≥ 60% diameter stenosis. These patients will be asked to undergo a carotid PET/MRI at a single time point 12-24 hours after intravenous injection of the 64Cu-CANF-Comb radiotracer.
Based on promising results from a proof of concept study, 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 or other carotid imaging ≥ 60% diameter stenosis. These patients will be asked to undergo a carotid PET/MRI at a single time point 12-24 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. While 12-18 months is the preferred window for repeat PET/MRI, if imaging during this time frame is not achievable, the patient may return anytime throughout the remainder of the study. PET/MRI changes over time 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 (12-24 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 (+/- 5 days) 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Optimal Medical Therapy (OMT) alone. | – | Drug: 64Cu-25%-CANF-CombAsymptomatic carotid artery stenosis (ACAS) patients with known carotid artery atherosclerosis by ultrasound/Doppler or other carotid imaging ≥ 60% diameter stenosis who are clinically referred for OMT alone. |
| Patients treated with OMT and carotid endarterectomy (CEA). | – | Drug: 64Cu-25%-CANF-CombAsymptomatic carotid artery stenosis (ACAS) patients with known carotid artery atherosclerosis by ultrasound/Doppler or other carotid imaging ≥ 60% diameter stenosis who are clinically referred for OMT and CEA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals ≥18 years of age with asymptomatic carotid artery stenosis.
Key inclusion criteria (3 listed)
- Adults, 18 years of age or older
- Asymptomatic carotid artery stenosis patients who have undergone carotid Doppler/ultrasound imaging or other carotid 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.
Key exclusion criteria (8 listed)
- 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 on the ipsilateral side.
- Past medical history of TIA or stroke within the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 64Cu-25%-CANF-CombPatients treated with OMT alone that are not treated with CEA will receive an intravenous injection of 2-6 mCi of 64Cu-25%-CANF-Comb radiotracer for PET/MR imaging at the initial imaging visit and at 12-18 months, or earlier if they develop symptoms. While 12-18 months is the preferred window for repeat imaging, if imaging during this time frame is not achievable, the patient may return anytime throughout the remainder of the study. | Drug | Patients treated with Optimal Medical Therapy (OMT) alone. |
| 64Cu-25%-CANF-CombPatients treated with OMT and CEA will receive an intravenous injection of 2-6 mCi of 64Cu-25%-CANF-Comb radiotracer for PET/MR imaging at the initial imaging visit. | Drug | Patients treated with OMT and carotid endarterectomy (CEA). |
Primary outcome
Number of patients reporting ipsilateral ischemic cerebrovascular event (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.
2 secondary outcomes
Changes in 64Cu-CANF-Comb PET signal - OMT
Time frame: 12-18 months (preferred); through study completion, up to 4 years.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pamela Woodard, MD principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Atherosclerosis and Asymptomatic Carotid Artery Stenosis, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Molly Mohrman (314-747-4633, mohrmanm@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients reporting ipsilateral ischemic cerebrovascular event (TIA, stroke) or remote ipsilateral carotid intervention (time frame: Through study completion, up to 4 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.