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OpenTrials
Completed

NCT Number: NCT02417688

PET Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis

To demonstrate feasibility of imaging Cu[64]-25%-CANF-Comb uptake in the atherosclerosis of the carotid artery of patients for whom carotid artery endarterectomy surgery is planned in comparison to the carotid artery for which intervention is not planned.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University in St.Louis

St Louis, Missouri, 63110, United States

About this study

This study is a single center, open-label baseline controlled imaging study designed to demonstrate feasibility of PET imaging of radiopharmaceutical nanoparticle Cu[64]-25%CANF-Comb uptake by PET-MR. Patients will undergo Cu[64]-25%CANF-Comb PET-MR imaging of both carotid arteries. Both carotid arteries will be imaged at the same time. We hope to demonstrate differences in PET SUV (Standardized Uptake Value) in the significantly atherosclerotic artery in patients who will be going to carotid endarterectomy surgery in comparison to the PET SUV in the artery that is not significantly diseased (ie; the artery that will not undergo surgery) . We also will determine whether PET SUV of the Cu[64]-25%CANF-Comb by the plaque correlates to the American Heart Association classifications of atherosclerosis and tissue presence of NPR-C in the ex vivo carotid endarterectomy specimen post surgery as measured by RT-PCR.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with carotid atherosclerosis
  • Patients must be scheduled for carotid intervention (endarterectomy surgery)
  • Signed informed consent.

Exclusion criteria

  • Unstable clinical conditions
  • Pregnancy and lactation
  • Inability to lie still for up to 60 min with arms down at sides for PET-MR imaging
  • Unwilling to comply with study procedures and unavailable for the duration of the study.
  • Pacemakers, brain aneurysm clip, shrapnel and other typical contraindications for MRI imaging.
  • Inability to provide written informed consent.

Treatment and study plan

Cu[64]-25%-CANF-Comb PET-MR

Device

Single IV injection of a novel radiopharmaceutical for diagnostic imaging of atherosclerosis by PET-MR

Other names: Cu[64]-25%-CANF-Comb

Primary outcomes

  1. PET SUV (Standardized Uptake Value)

    Time frame: 22-26 hours

    Difference in SUV between the carotid with atherosclerosis (carotid artery to be undergo surgery) and the carotid artery without significant disease (artery for which surgery is not planned).

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With [64]Cu-25%CANF-Comb

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Apr 16, 2015
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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