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

NCT07800481 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 202607105-VolunteerR01HL159803
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adult; Healthy

Keywords

biodistribution; safety; radiotracer; Positron Emission Tomography (PET); Cardiovascular Diseases; Atherosclerosis

Outcome Measures

Primary Outcomes (3)

• Organ radiation dose of 64Cu-NODAGA-CANF

  Tracer biodistribution will be evaluated by measuring uptake of 64Cu-NODAGA-CANF in various organs as determined by PET-CT imaging. The organs used to describe the biodistribution of the radiopharmaceutical will be blood, liver, kidneys, spleen, heart, marrow, and muscle as appropriate as seen as organs showing significant uptake. Only organs and tissues containing a visible accumulation of activity will be selected for image quantification. Regions of Interest (ROIs) will be drawn to measure average activity concentration in each organ or tissue. Time activity curves will be then constructed from these values. Time Integrated Activity (formerly known as residence times) will be calculated by analytical or numerical integration of the fitted time taking into account the radioactive decay of 64Cu. Dose calculations will be performed using MIRDCalc software for either the adult male or adult female model as appropriate for each patient using the calculated Time Integrated Activity.

  Up to 48 hours post-injection of 64Cu-NODAGA-CANF

• Effective Dose of 64Cu-NODAGA-CANF

  Effective dose of 64Cu-NODAGA-CANF calculated by analysis of biodistribution of 64Cu-NODAGA-CANF from PET-CT images. Dose calculations will be performed using MIRDCalc software for either the adult male or adult female model as appropriate for each patient using the calculated Time Integrated Activity (residence times).

  Up to 48 hours post-injection of 64Cu-NODAGA-CANF

• Number of participants with treatment-related adverse events

  Subjects will be monitored for adverse events from the time of consent through follow-up. Follow-up will occur by telephone 2-3 days after discharge. Adverse events are defined as any untoward medical occurrence in a subject who receives 64Cu-NODAGA-CANF, including any unfavorable or unintended sign, symptom, or disease temporally associated with the injection of 64Cu-NODAGA-CANF. Treatment-related means there is a reasonable possibility that the incident, experience, or outcome was or may have been caused by the treatment.

  From baseline up to 2-3 days following 64Cu-NODAGA-CANF dose injection

Study Arms (1)

64Cu-NODAGA-CANF Dosimetry Group

EXPERIMENTAL

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).

Drug: 64Cu-NODAGA-CANF

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).

64Cu-NODAGA-CANF Dosimetry Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Molly Mohrman

CONTACT

314-747-4633; mohrmanm@wustl.edu

Pamela K. Woodard, MD

CONTACT

314-362-7100; woodardp@wustl.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: September 2, 2026
• Study Start: August 19, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

US (1)