40 Participants NeededMy employer runs this trial

11C-ARMI for Healthy Subjects

TN
RB
Overseen ByRobert B Innis, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Mental Health (NIMH)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radioactive tracer called 11C-ARMI in healthy individuals. The tracer, a special type of drug, helps researchers visualize chemicals in the body during imaging scans, potentially aiding in the study of diseases like Alzheimer's and Parkinson's. Participants will undergo PET/CT scans, and some may also have MRI scans to evaluate the tracer's effectiveness. Ideal candidates are healthy individuals who have been screened under specific protocols and can complete all study procedures. As a Phase 1 trial, this research focuses on understanding the tracer's function in people, offering participants the unique opportunity to be among the first to receive this new treatment.

Do I need to stop taking my current medications for the trial?

Yes, you must stop taking medications that significantly bind to alpha-1 adrenoceptors, alter norepinephrine release, or lower blood pressure, including certain blood pressure medications and erectile dysfunction drugs, within five elimination half-lives before the PET scan.

What prior data suggests that this tracer is safe for use in humans?

In this trial, researchers are testing a new substance called 11C-ARMI. No specific safety information from past studies exists for 11C-ARMI itself. As a Phase 1 trial, this marks the first time the treatment is tested in humans. Phase 1 trials primarily focus on safety, so researchers exercise great caution. They closely monitor participants for any side effects or unexpected reactions.

Reaching this phase usually indicates that earlier lab and animal tests did not reveal major safety issues. However, as this is the first stage of human testing, unknown risks may still exist. Participants in these trials help researchers understand how well people tolerate the treatment, which is crucial for future studies.12345

Why are researchers excited about this trial?

Researchers are excited about the 11C-ARMI trial because it explores a novel imaging technique rather than a treatment. Unlike traditional imaging methods used for diagnostic purposes, 11C-ARMI is designed to enhance the visualization of biological processes at a molecular level in healthy individuals. This approach could provide unprecedented insights into how the human body functions in real time, potentially leading to breakthroughs in understanding various conditions and developing new diagnostic tools. By focusing on healthy subjects, the trial aims to establish a baseline of normal biological activity, which is crucial for identifying abnormalities in disease states.

What evidence suggests that this tracer is effective for imaging in healthy subjects?

Research has shown that 11C-ARMI is a new type of radioactive substance used in imaging scans. While direct evidence of its effectiveness for diseases like Alzheimer's or Parkinson's is not yet available, this tracer is being developed to highlight specific chemicals in the body. This development could enhance understanding of these conditions. Tracers like 11C-ARMI attach to certain molecules, making them visible in scans, which is crucial for diagnosing and studying diseases. In this trial, all participants will undergo the same tests to assess the safety of 11C-ARMI and its visibility in the body.678910

Who Is on the Research Team?

RB

Robert B Innis, M.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 and older who have already been screened in specific earlier studies. Participants should not have any major health issues.

Inclusion Criteria

I am healthy according to my medical history, exam, and lab tests.
Must have undergone a screening assessment under protocol 01-M-0254 or 17M0181 for NIMH Intramural Studies
Willingness to complete all study procedures including MRI tests
See 4 more

Exclusion Criteria

Pregnancy or breastfeeding
I have not had recent radiation that would exceed safe limits with this study.
Clinically significant abnormalities on EKG or laboratory testing including CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen)
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Not specified

Imaging

Participants undergo PET/CT scans with the 11C-ARMI tracer to study brain uptake and perform kinetic modeling

1-2 visits
1 visit (whole body) or up to 2 visits (brain)

Follow-up

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

Not specified

What Are the Treatments Tested in This Trial?

Interventions

  • 11C-ARMI

Trial Overview

Researchers are testing a new imaging tracer called 11C-ARMI to see how it works during PET/CT scans of the brain or whole body in healthy people. Some may also get an MRI scan of the brain.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: One-armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Mental Health (NIMH)

Lead Sponsor

Trials
3,007
Recruited
2,852,000+

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