An Early Phase 1 interventional study of 64Cu-NODAGA-CANF in Healthy Adult and Healthy, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Washington University School of Medicine · Early Phase 1, Interventional, and Diagnostic
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.
This study is a single center, open-label baseline controlled imaging study designed to demonstrate safety, biodistribution and dosimetry of the radiopharmaceutical 64Cu-NODAGA-CANF (Cu = copper; CANF = C-type Atrial Natriuretic Factor) in healthy adult volunteers. By definition a "healthy" volunteer is an individual who, by physical exam and baseline electrocardiogram, has no evidence of cardiovascular disease and, by history, is not under the care of a physician for any active medical conditions.
Each volunteer will receive a single intravenous bolus injection of less than 4 mCi of the investigational radiotracer 64Cu-NODAGA-CANF followed by whole body static PET-CT imaging at 3 or 4 imaging time points up to 48 hours post-injection (30-60 minutes, 2-6 hours, 18-24 hours, and 40-48 hours). For safety assessment, a physical examination will be performed at baseline and prior to discharge to assess for interval change. An EKG will be obtained at screening/baseline pre-injection, 90 minutes post-injection, and prior to discharge on the first day to assess for interval change. Vital signs will be obtained at baseline pre-injection, 15 minutes post-injection, 90 minutes post-injection, and prior to discharge on the first day to assess for interval change. Additional vital sign measurements will be obtained at each imaging session prior to imaging and post-scan prior to discharge. Blood will be drawn at screening or baseline, 90 minutes post-injection, and prior to discharge on the first day to assess for interval change in serum chemistries and complete blood count. Urine will be collected at screening or baseline, 90 minutes post-injection, and prior to discharge on the first day to assess for interval change in urinalysis results.
Blood samples will be obtained from all subjects for radiolabeled metabolite analysis. Two-mL blood samples will be obtained at 5 minutes and 60 minutes post 64Cu-NODAGA-CANF injection. The amount of radioactive tracer in the urine will also be assessed on all 8 adult normal volunteer subjects. Subjects will be asked to void his/her bladder before injection of 64Cu-NODAGA-CANF and will be asked to void after each imaging time point. Urine will be collected at each of these time points. Telephone follow-up will occur within 48-72 hours (2-3 days) after discharge.
Tracer biodistribution will be evaluated by measuring tracer uptake in various organs in the torso on the PET-CT scan. 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. Values in three-dimensional regions of interest (3D-ROIs) traced on the contour of the organs will be used.
The percent injected dose values will be calculated by extrapolating the measured activity concentration in each organ to the whole organ using standard organ and tissue volumes and dividing by the injected activity. Time activity curves will be then constructed from these values for all organs for which ROIs were drawn including liver, spleen, kidneys, marrow, muscle, blood pool and remainder of body by combining the data from all the patients, as seen appropriate in the PET images. The blood content of each organ will be included with the organ where possible rather than assigning it uniformly to the remainder of body. Data from individual patients will be fitted by a least-squares minimization to achieve along with appropriate values of % ID at t = 0.
Time Integrated Activity (formerly known as residence times) for each organ or tissue will be calculated by analytical or numerical integration of the fitted time-activity curves taking into account the radioactive decay of 64Cu. Time Integrated Activity (residence times) will be expressed in hours.
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).
1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.
This study's planned enrollment of 8 is below the median of 100 across 879 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Compared within Atherosclerosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cardiovascular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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).
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.
Time frame: 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).
Time frame: 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.
Time frame: From baseline up to 2-3 days following 64Cu-NODAGA-CANF dose injection
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for May 2027, 9 months after the start.
Of 31 phase 1 interventional studies under Atherosclerosis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 41. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Washington University School of Medicine →