Clinical trial NCT02417688: PET Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis
Official title: PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With [64]Cu-25%CANF-Comb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carotid Atherosclerosis
Keywords: carotid atherosclerosis, PET imaging agent
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PET SUV (Standardized Uptake Value)
timeFrame: 22-26 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St.Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Pamela K Wooderd, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu Y, Pressly ED, Abendschein DR, Hawker CJ, Woodard GE, Woodard PK, Welch MJ. Targeting angiogenesis using a C-type atrial natriuretic factor-conjugated nanoprobe and PET. J Nucl Med. 2011 Dec;52(12):1956-63. doi: 10.2967/jnumed.111.089581. Epub 2011 Nov 2.
citation: Liu Y, Abendschein D, Woodard GE, Rossin R, McCommis K, Zheng J, Welch MJ, Woodard PK. Molecular imaging of atherosclerotic plaque with (64)Cu-labeled natriuretic peptide and PET. J Nucl Med. 2010 Jan;51(1):85-91. doi: 10.2967/jnumed.109.066977. Epub 2009 Dec 15.