PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
NCT07916883, Not yet recruiting, Washington University School of Medicine
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite) | ClinicalTrials.gov |
| NCT number | NCT07916883 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Washington University School of Medicine | ClinicalTrials.gov |
| Conditions | Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic, Asymptomatic Carotid Artery Stenosis | ClinicalTrials.gov |
| Interventions | 64Cu-NODAGA-CANF, Optimal Medical Therapy (OMT), Carotid Endarterectomy (CEA) surgery | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Comparison of 64Cu-NODAGA-CANF PET SUV (Standardized Uptake Value) between the atherosclerosis of the target diseased carotid artery and the non-diseased contralateral carotid artery or non-diseased vertebral artery | Up to 4 hours post-injection of 64Cu-NODAGA-CANF | PET uptake of 64Cu-NODAGA-CANF will be quantified as SUV. For each subject, PET SUV will be measured in the atherosclerosis of the diseased carotid artery and in a region of non-disease in the contralateral carotid artery, or if the contralateral carotid is completely diseased, a portion of non-diseased vertebral artery. Mean SUV in the atherosclerosis of the diseased carotid arteries will be compared to mean SUV in the non-diseased contralateral carotid arteries or non-diseased vertebral arteries. | ClinicalTrials.gov |
| Secondary | Correlation of 64Cu-NODAGA-CANF PET uptake to American Heart Association (AHA) stage of atherosclerotic plaque as determined by MRI | Up to 4 hours post-injection of 64Cu-NODAGA-CANF | Patients with carotid atherosclerosis will be imaged with 64Cu-NODAGA-CANF PET-MR. MRI is acquired simultaneously with 64Cu-NODAGA-CANF PET. MR images will be evaluated for AHA plaque stage. AHA grades for atherosclerosis disease progression are I-II) near normal wall thickness, no calcification, III) diffuse intimal thickening or small eccentric plaque with no calcification, IV-V) plaque with a lipid or necrotic core surrounded by fibrous tissue with possible calcification, and VI) complicated lesion due to fissure, hemorrhage, or thrombus. PET uptake of 64Cu-NODAGA-CANF will be quantified as SUV. PET signal (SUV) will be compared between patients with different AHA stages of atherosclerotic plaque. | ClinicalTrials.gov |
| Secondary | Correlation of 64Cu-NODAGA-CANF PET uptake to absence or presence of atherosclerosis as determined by MRI | Up to 4 hours post-injection of 64Cu-NODAGA-CANF | Patients with carotid atherosclerosis will be imaged with 64Cu-NODAGA-CANF PET-MR. MRI is acquired simultaneously with 64Cu-NODAGA-CANF PET. MR images will be evaluated for absence or presence of atherosclerosis. PET uptake of 64Cu-NODAGA-CANF will be quantified as SUV. PET signal (SUV) will be compared between patients with absence or presence of atherosclerosis. | ClinicalTrials.gov |
| Secondary | Correlation of 64Cu-NODAGA-CANF PET uptake to absence or presence of lipid core as determined by MRI | Up to 4 hours post-injection of 64Cu-NODAGA-CANF | Patients with carotid atherosclerosis will be imaged with 64Cu-NODAGA-CANF PET-MR. MRI is acquired simultaneously with 64Cu-NODAGA-CANF PET. MR images will be evaluated for absence or presence of lipid core. PET uptake of 64Cu-NODAGA-CANF will be quantified as SUV. PET signal (SUV) will be compared between patients with absence or presence of lipid core. | ClinicalTrials.gov |
| Secondary | Correlation of 64Cu-NODAGA-CANF PET uptake to absence or presence of hemorrhage as determined by MRI | Up to 4 hours post-injection of 64Cu-NODAGA-CANF | Patients with carotid atherosclerosis will be imaged with 64Cu-NODAGA-CANF PET-MR. MRI is acquired simultaneously with 64Cu-NODAGA-CANF PET. MR images will be evaluated for absence or presence of hemorrhage. PET uptake of 64Cu-NODAGA-CANF will be quantified as SUV. PET signal (SUV) will be compared between patients with absence or presence of hemorrhage. | ClinicalTrials.gov |
| Secondary | Correlation of 64Cu-NODAGA-CANF PET uptake to outcomes | Up to 4 years following PET-MR imaging | PET uptake of 64Cu-NODAGA-CANF will be quantified as SUV. The investigators will determine the ability of 64Cu-NODAGA-CANF to risk stratify ACAS patients with respect to patient outcomes. Patients will be contacted every 3 months after PET-MR imaging to assess for interval ipsilateral ischemic cerebrovascular event (transient ischemic attack (TIA), stroke) or remote ipsilateral carotid intervention. PET signal will be assessed as a marker of risk for event or progression to CEA surgery. 64Cu-NODAGA-CANF PET signal (SUV) will compared between patients who experienced or did not experience an ipsilateral ischemic cerebrovascular event (TIA, stroke) or remote ipsilateral carotid intervention (carotid endarterectomy (CEA) surgery or stent placement). | ClinicalTrials.gov |
| Secondary | Correlation of 64Cu-NODAGA-CANF PET uptake to American Heart Association (AHA) stage of atherosclerotic plaque as determined by histology on ex vivo tissue specimens for patients undergoing CEA surgery | Immediately after surgery | PET uptake of 64Cu-NODAGA-CANF will be quantified as SUV. In patients who undergo CEA, the ex vivo post-operative plaque specimen will be collected. Tissue measurements will include American Heart Association (AHA) plaque stage as an indicator of plaque vulnerability. AHA stage of atherosclerotic plaque will be determined by assessment of hematoxylin and eosin (H\&E), Verhoeff-Van Gieson (VVG), and pentachrome stained specimens. AHA grades for atherosclerosis disease progression are I) intimal thickening, II) fatty streak, III) preatheroma, IV) atheroma, Va) fibroatheroma, Vb) calcified plaque, Vc) fibrous plaque and VI) complicated lesion due to fissure, hemorrhage, or thrombus. 64Cu-NODAGA-CANF PET signal (SUV) obtained from images pre-surgery will be compared between patients with different AHA stages of atherosclerotic plaque on the surgical tissue specimen. | ClinicalTrials.gov |
| Secondary | Correlation of 64Cu-NODAGA-CANF PET uptake to expression of targeted receptor, NPR-C, by immunohistochemistry on ex vivo tissue specimens for patients undergoing CEA surgery | Immediately after surgery | PET uptake of 64Cu-NODAGA-CANF will be quantified as SUV. In patients who undergo CEA, the ex vivo post-operative plaque specimen will be collected. Tissue measurements will include expression of NPR-C by immunohistochemistry. 64Cu-NODAGA-CANF PET signal (SUV) obtained from images pre-surgery will be correlated to expression of NPR-C on the surgical tissue specimen. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
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Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
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Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
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Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
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Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01HL159803 | A Receptor-Targeted Nanoparticle PET Tracer in Human Carotid Atherosclerosis | WOODARD, PAMELA K; ZAYED, MOHAMED A. | WASHINGTON UNIVERSITY | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2022 to 2025 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
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Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)