[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07686393":3,"trial-entities:NCT07686393":89,"trial-summary:NCT07686393":92},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":36,"secondary_outcomes":41,"sex":44,"minimum_age":45,"maximum_age":46,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":52,"locations":55,"central_contacts":72,"overall_officials":81,"references":84,"see_also_links":85},"NCT07686393","10002497","PET Imaging of Noradrenergic Transmission in the Brain","RECRUITING","2030-02-20","2026-07-02","2026-08-05","2026-08-10","National Institute of Mental Health (NIMH)","NIH",null,"Background:\n\nResearchers have developed a new radioactive tracer (11C-ARMI). A tracer is a drug that attaches itself to other chemicals in the body and lights up so that the chemicals can be seen in imaging scans. The new tracer may be able to help them with many diseases, such as Alzheimer s disease and Parkinson s disease. Researchers want to test the new tracer in healthy people.\n\nObjective:\n\nTo test a new tracer (11C-ARMI) during imaging scans of the brain and body in healthy people.\n\nEligibility:\n\nHealthy people aged 18 years and older. They must have been screened under protocols 01-M-0254 or 17M0181.\n\nDesign:\n\nAll participants will have a positron emission tomography (PET)\u002Fcomputed tomography (CT) scan. Before the scan, they will have blood and urine tests and a test of their heart function. The tracer will be given through a tube attached to a needle inserted into a vein in the arm. They will lie on a padded bed that fits inside a doughnut-shaped machine; the machine uses x-rays to create images of the inside of the body.\n\nSome participants will have a PET\u002FCT scan of their whole body. They will need only 1 visit.\n\nSome participants will have a PET\u002FCT scan of only their brain. They will have up to 2 visits. On the second visit, they will have a magnetic resonance imaging (MRI) scan of the brain. For the MRI, they will lie on a table that slides into a cylinder. The MRI uses magnetic fields to create images of the inside of the body.\n\nParticipants will receive a follow-up call to check on their well-being after their PET\u002FCT scans.","Study Description:\n\nThis study is intended to provide information on the novel 11C-ARMI radioligand and its ability to localize and measure Alpha-1A Adrenoreceptor (alpha-1A AR) in the brain and body of healthy volunteers.\n\nObjectives:\n\nPrimary Objective:\n\nTo study the brain uptake of 11C-ARMI and perform kinetic modeling of 11C-ARMI in healthy volunteers.\n\nSecondary Objectives:\n\nTo study brain retest variability and reliability, biodistribution, and dosimetry of 11C-ARMI in healthy volunteers.\n\nEndpoint:\n\nPrimary Endpoint:\n\nFor both objectives, the primary endpoint is receptor density measured as distribution volume (VT).\n\nSecondary Endpoint:\n\nRadiation burden to the body and expressed as Effective Dose (ED).",[18],"Healthy",[20,21,22,18],"Positron Emission Tomography (PET) Imaging","11C-ARMI","Alpha-1A Adrenoreceptor ( 1A-AR)","INTERVENTIONAL","DIAGNOSTIC",[26],"PHASE1",{"count":28,"type":29},40,"ESTIMATED",[31],{"type":32,"name":21,"description":33,"armGroupLabels":34},"DRUG","Injected IV followed by PET scanning",[35],"One-arm",[37],{"measure":38,"description":39,"timeFrame":40},"To measure distribution volume","Target quantification","24 months",[42],{"measure":43,"timeFrame":40},"To measure variability distribution volume","ALL","18 Years","105 Years",true,{"inclusion":49,"exclusion":50,"raw_text":51},[],[],"* INCLUSION CRITERIA:\n\n  1. Aged 18 years or older.\n  2. Must have undergone a screening assessment under protocol 01-M-0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants or 17M0181 Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies.\n  3. Be healthy based on medical history, physical examination, and laboratory testing.\n  4. Able to understand and willingness to provide informed consent.\n  5. Willingness to complete all study procedures including MRI tests.\n  6. Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n  7. Agree to adhere to the lifestyle considerations\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n2. Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits.\n3. Inability to lie flat on camera bed for at least two hours, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).\n4. HIV infection.\n5. Pregnancy or breastfeeding.\n6. Must not have substance use disorder or alcohol use disorder.\n7. Unable to travel to the NIH.\n8. Unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n9. Taking medications reported to have significant binding to alpha-1 adrenoceptors, medications that that alter norepinephrine release, or medications that lower blood pressure including antihypertensives, diuretics, or phosphodiesterase-5(PDE-5) inhibitors (e.g. sildenafil, tadalafil, vardenafil) within five elimination halflives prior to any \\[11C\\]ARMI PET scan.\n10. Known hypersensitivity to quinazoline-class medications (e.g., prazosin), defined as any prior allergic or clinically significant adverse reaction requiring discontinuation or medical evaluation.\n11. Blood donation within 8 weeks (2 months) before study participation, or unwillingness to avoid blood donation for 8 weeks (2 months) after the study.",[53,54],"ADULT","OLDER_ADULT",[56],{"facility":57,"status":7,"city":58,"state":59,"zip":60,"country":61,"contacts":62,"geoPoint":69},"National Institutes of Health Clinical Center","Bethesda","Maryland","20892","United States",[63],{"name":64,"role":65,"phone":66,"phoneExt":67,"email":68},"NIH Clinical Center Office of Patient Recruitment (OPR)","CONTACT","800-411-1222","TTY dial 711","ccopr@nih.gov",{"lat":70,"lon":71},38.98067,-77.10026,[73,77],{"name":74,"role":65,"phone":75,"email":76},"Tara N Turon, C.R.N.P.","(301) 827-6599","tara.turon@nih.gov",{"name":78,"role":65,"phone":79,"email":80},"Robert B Innis, M.D.","(301) 594-1368","robert.innis@nih.gov",[82],{"name":78,"affiliation":12,"role":83},"PRINCIPAL_INVESTIGATOR",[],[86],{"label":87,"url":88},"NIH Clinical Center Detailed Web Page","https:\u002F\u002Fclinicalstudies.info.nih.gov\u002Fcgi\u002Fdetail.cgi?A_002497-M.html",{"nct_id":4,"conditions":90,"biomarkers":91},[18],[],{"nct_id":4,"found":47,"summary":93,"prompt_version":103},{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is an interventional study planning to enroll 40 healthy participants. All participants will receive an injection of 11C-ARMI followed by a PET\u002FCT scan.","completed","PET Imaging with 11C-ARMI in Healthy Volunteers","This study is testing a new radioactive tracer called 11C-ARMI. A tracer is a special drug that attaches to chemicals in your body and lights up during imaging scans, helping doctors see them better. Researchers want to see how 11C-ARMI works in healthy people during a PET (positron emission tomography) scan, which is a type of imaging scan. They will be looking at how much of the tracer is taken up by your brain and body. This information could help them understand diseases like Alzheimer's and Parkinson's in the future. You can join if you are 18 or older and have been screened under specific NIMH protocols. The study aims to measure the distribution volume of the tracer in the brain. The current status of this study is unclear.","The primary endpoint, distribution volume, will be measured at 24 months.",129,"You will receive an intravenous (IV) injection of 11C-ARMI, followed by PET scanning.","Not stated in the trial record.",[21],"v2"]