CANF-Comb-II PET-MR in Atherosclerosis Multisite

NCT05838547 | Recruiting FDA Drug

• 3 other identifiers: 202210116123,617R01HL159803
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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).

Conditions

Carotid Atherosclerosis; Asymptomatic Carotid Artery Stenosis; Carotid Artery Atheroma

Keywords

Stroke; TIA; Vascular Disease; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, up to 4 years.

Secondary Outcomes (2)

• Changes in 64Cu-CANF-Comb PET signal - OMT

  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

  Immediately after surgery.

Study Arms (2)

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.

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.

Drug: 64Cu-25%-CANF-Comb

Interventions

64Cu-25%-CANF-Comb DRUG

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.

Patients treated with Optimal Medical Therapy (OMT) alone.

Eligibility Criteria

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

Study Population

Individuals ≥18 years of age with asymptomatic carotid artery stenosis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Cedars-Sinai Medical Center: collaborator
• University of California, Santa Barbara: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63130-2344, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Carotid plaque tissue specimens will be collected at the time of surgery.

MeSH Terms

Conditions

Carotid Artery Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Pamela Woodard, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Molly Mohrman

CONTACT

314-747-4633; mohrmanm@wustl.edu

Pamela Woodard, MD

CONTACT

314-362-7100; woodardp@wustl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HM Wilson Professor of Radiology

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: May 1, 2023
• Study Start: March 21, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)