Recruiting
Early Phase 1

64Cu-NODAGA-CANF

Sponsor:

Washington University School of Medicine

Code:

NCT07800481

Conditions

Healthy Adult

Healthy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

64Cu-NODAGA-CANF

Study Details

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

Study ID

NCT07800481

Start date

Aug 19, 2026

Status verified date

Aug, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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).

Interventions

64Cu-NODAGA-CANF

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 ]
  • Effective Dose of 64Cu-NODAGA-CANF [ Time Frame: Up to 48 hours post-injection of 64Cu-NODAGA-CANF ]
  • Number of participants with treatment-related adverse events [ Time Frame: From baseline up to 2-3 days following 64Cu-NODAGA-CANF dose injection ]

Central Contacts and Locations

Central contacts

Molly Mohrman

314-747-4633mohrmanm@wustl.edu

Pamela K. Woodard, MD

314-362-7100woodardp@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Pamela K. Woodard, MD

314-362-7100woodardp@wustl.edu

Principal Investigator:

Pamela K. Woodard, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-09-02.