PET Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Volunteer - Dosimetry Study)

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07800481
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Healthy
  • Healthy Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 64Cu-NODAGA-CANF — DRUG
    Single intravenous (IV) injection of less than 4 mCi of 64Cu-NODAGA-CANF followed by PET-CT imaging at 3 or 4 time points up to 48 hours post-injection (30-60 minutes, 2-6 hours, 18-24 hours and 40-48 hours).

Study Details

The goal of this clinical trial is to determine the biodistribution, safety, and calculate the radiation dosimetry of the novel atherosclerotic PET imaging radiotracer, 64Cu-NODAGA-CANF, in normal healthy adult volunteers. Participants will receive a single intravenous administration of 64Cu-NODAGA-CANF and then undergo PET-CT imaging at various time points following injection. Safety will be assessed through evaluation of vital signs, clinical laboratory tests, physical examination, and electrocardiograms (EKGs). Telephone follow-up will occur 2-3 days after discharge.

Key Dates

First listed
Sep 2, 2026
Start date
Aug 19, 2026
Status verified
Aug 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 64Cu-NODAGA-CANF Dosimetry Group
    Healthy adult normal volunteers will receive a single intravenous (IV) injection of less than 4 mCi of 64Cu-NODAGA-CANF followed by PET-CT imaging at 3 or 4 time points up to 48 hours post-injection (30-60 minutes, 2-6 hours, 18-24 hours and 40-48 hours).

Primary Outcome Measure

Organ radiation dose of 64Cu-NODAGA-CANF [ Time Frame: Up to 48 hours post-injection of 64Cu-NODAGA-CANF ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Pamela K. Woodard, MD
[email protected]
314-362-7100
Pamela K. Woodard, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Washington University School of Medicine· St Louis, MO

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