Recruiting
Phase 1

11C-ARMI

Sponsor:

National Institute of Mental Health (NIMH)

Code:

NCT07686393

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

11C-ARMI

Study Details

Brief summary:

Background:

Researchers 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.

Objective:

To test a new tracer (11C-ARMI) during imaging scans of the brain and body in healthy people.

Eligibility:

Healthy people aged 18 years and older. They must have been screened under protocols 01-M-0254 or 17M0181.

Design:

All participants will have a positron emission tomography (PET)/computed 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.

Some participants will have a PET/CT scan of their whole body. They will need only 1 visit.

Some participants will have a PET/CT 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.

Participants will receive a follow-up call to check on their well-being after their PET/CT scans.

Conditions

Healthy

Study ID

NCT07686393

Start date

Aug 14, 2026

Status verified date

Aug 27, 2026

Completion date

Feb 20, 2030

Anticipated

Primary completion date

Feb 5, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: One-arm

All subjects will receive the same tests.

Interventions

11C-ARMI

Injected IV followed by PET scanning

Primary outcome measure

  • To measure distribution volume [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Mental Health (NIMH)

Last update posted

Aug 31, 2026

Last verified

Aug 27, 2026

Keywords

  • Positron Emission Tomography (PET) Imaging
  • 11C-ARMI
  • Alpha-1A Adrenoreceptor ( 1A-AR)
  • Healthy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Mental Health (NIMH) on 2026-08-31.