CANF-Comb-II PET-MR in Atherosclerosis Multisite

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Apr 27, 2023

Keywords

ClinConnect Summary

The CANF-Comb-II PET-MR study is looking to understand more about the type of plaque that builds up in the arteries of patients who have narrowed carotid arteries but do not show any symptoms. The main goal is to see how well a special imaging technique called 64Cu-CANF-Comb positron emission tomography (PET) can help predict the risk of stroke or other serious events in these patients. Researchers also want to learn more about a specific protein called Natriuretic Peptide Receptor C (NPRC) and how it affects the progression of carotid artery disease.

To participate in this study, you need to be at least 18 years old and have had a recent ultrasound showing that your carotid artery is at least 60% narrowed. Participants will undergo a PET-MRI scan, which is a combination of two imaging tests that allows doctors to see how the plaque in your arteries is behaving. This study is open to all genders and is currently recruiting. It’s important to note that those with certain medical conditions, past procedures on the carotid artery, or who are pregnant may not be eligible. If you join, you’ll be contributing to important research that could help improve how we predict and manage stroke risk in patients with carotid artery issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.