💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
HealthTeky