Brain imaging with a new tracer to map alpha-1A receptors in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study assesses the brain uptake, distribution, and imaging reliability of the novel radioligand 11C-ARMI in healthy volunteers. Participants will undergo PET/CT scanning with arterial-artery and standard safety assessments, followed by kinetic modeling to estimate receptor density. The study also evaluates test-retest variability, biodistribution, and the radiation dose from the tracer. Enrollment is limited to adults meeting prior screening criteria and able to complete MRI and consent procedures.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:

  1. Aged 18 years or older.
  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.
  3. Be healthy based on medical history, physical examination, and laboratory testing.
  4. Able to understand and willingness to provide informed consent.
  5. Willingness to complete all study procedures including MRI tests.
  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.
  7. Agree to adhere to the lifestyle considerations

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).
2. Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits.
3. 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).
4. HIV infection.
5. Pregnancy or breastfeeding.
6. Must not have substance use disorder or alcohol use disorder.
7. Unable to travel to the NIH.
8. 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.
9. 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.
10. Known hypersensitivity to quinazoline-class medications (e.g., prazosin), defined as any prior allergic or clinically significant adverse reaction requiring discontinuation or medical evaluation.
11. Blood donation within 8 weeks (2 months) before study participation, or unwillingness to avoid blood donation for 8 weeks (2 months) after the study.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Robert B Innis, M.D. — National Institute of Mental Health (NIMH)
• Study coordinator: Tara N Turon, C.R.N.P.
• Email: tara.turon@nih.gov
• Phone: (301) 827-6599

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.