PET imaging of NPR-C in healthy adults using 64Cu-NODAGA-CANF (dosimetry)
Official title: PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Volunteer - Dosimetry Study)
Run by Washington University School of Medicine · NCT07800481 · Data updated 2026-11-12
This study tests how the radiotracer 64Cu-NODAGA-CANF distributes in the body and its safety in healthy adults.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 8 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | August 19, 2026 |
| Main results expected | May 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT07800481 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults 18 years or older with no cardiovascular disease who are willing to undergo PET-CT imaging and follow-up.
✕Probably not a fit
Participants with active cardiovascular disease or conditions affecting imaging or safety may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this early-phase dosimetry study, healthy volunteers receive a single IV dose of 64Cu-NODAGA-CANF and undergo multiple PET-CT scans over 48 hours to map biodistribution and estimate radiation dose. Safety is monitored with vital signs, labs, physical exams, and ECGs, with a telephone follow-up 2–3 days after discharge. The study is conducted at a single center and aims to establish radiotracer safety, distribution, and dosimetry prior to broader use. Eligible participants are adults without cardiovascular disease, including equal representation of sexes.
Why it matters
Potential benefit: If successful, the findings could enable safer and more accurate PET imaging of cardiovascular targets using this radiotracer.
How similar studies have gone: Previous imaging radiotracers have demonstrated feasible biodistribution and dosimetry assessments in healthy volunteers, supporting this approach as a foundational step.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults, 18 years of age or older. * Healthy adult normal volunteer subjects (4 males and 4 females). "Healthy adult normal volunteer subject" is someone who has volunteered to be imaged and who, based on physical exam and baseline electrocardiogram, has no evidence of cardiovascular disease and is not under the care of a physician for any active medical conditions. 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 above head for PET-CT. * Normal adult volunteer subjects with evidence of disease based on clinical evaluation and/or blood laboratory tests, which are judged by the Sponsor-Investigator or designee to interfere with the objectives of the protocol. * Prior history of carotid endarterectomy (CEA) or carotid artery stent procedure on the ipsilateral side. * Past medical history of transient ischemic attack (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. * 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. * 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.
Where it's running
-
Washington University School of Medicine
St Louis, Missouri, United States Recruiting
Study contacts
- Study coordinator: Molly Mohrman
- Email: mohrmanm@wustl.edu
- Phone: 314-747-4633
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.