PET Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Volunteer - Dosimetry Study)
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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). |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis, Missouri 63110
More Details
- NCT ID
- NCT07800481
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine
Detailed Description
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).