NCT07916883Not yet recruiting
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the feasibility of imaging atherosclerosis by 64Cu-NODAGA-CANF PET-MR in a pilot study of patients with asymptomatic carotid artery stenosis (ACAS). The main question it aims to answer is: Can 64Cu-NODAGA-CANF PET detect carotid atherosclerosis in patients with ACAS? Uptake of 64Cu-NODAGA-CANF as measured by PET-MR will also be correlated to anatomic features of plaque on MRI, outcomes for patients treated with optimal medical therapy (OMT) alone or OMT and carotid endarterectomy (CEA) surgery, and tissue measurements for patients undergoing CEA surgery. The ability of 64Cu-NODAGA-CANF to risk stratify ACAS patients treated with OMT alone with respect to patient outcomes will be determined. Participants will * Receive a single intravenous (IV) administration of 64Cu-NODAGA-CANF followed by dynamic PET-MR imaging for up to 60 minutes and a second optional scan between 1-4 hours post-injection. * Undergo physical examinations, vital sign measurements, and blood and urine collection for clinical laboratory tests. * Undergo standard of care treatment with either OMT alone or OMT and CEA surgery. * Be evaluated with phone interviews 48-72 hours (2-3 days) after discharge and every 3 months (+/- 5 days) to assess for ipsilateral ischemic cerebrovascular event (transient ischemic attack (TIA), stroke) or remote ipsilateral carotid intervention.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 29 Oct 2026
- Start date
- 18 Nov 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Stroke
- NCT number
- NCT07916883
What you commit to
- Study type: Observational
- Planned participants: 30
- From 18 Nov 2026 to the primary completion date, 31 May 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of carotid endarterectomy (CEA) or carotid artery stent procedure on the ipsilateral side.
- Claustrophobia or other preventing condition that has previously or would interfere with completion of imaging as outlined in the protocol.
- Participation in another research study with an investigational drug, including a diagnostic or therapeutic radiopharmaceutical, currently or within the last year.
Other illness
- Patients with an unstable clinical condition that in the opinion of the Sponsor-Investigator or designee precludes participation in the study.
- Past medical history of transient ischemic attack (TIA) or stroke within the last 6 months.
Lab values
- 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-NODAGA-CANF or documented post-menopausal defined as the cessation of menses for ≥ 12 months or documentation of having a bilateral oophorectomy and/or hysterectomy.
Other
- Inability to receive and sign informed consent.
- Inability to tolerate up to 60 minutes in a supine position with arms down at sides for PET-MR imaging.
- 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.).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.