[18F]-FTC-146 Imaging for Healthy Controls

(rSIG Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Stanford University

Must not be taking: Psychotropic medications

Disqualifiers: Psychiatric diagnosis, Pregnancy, Neurological problem, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how well the brain absorbs [18F]-FTC-146, a radiotracer used in imaging, in healthy individuals. The researchers seek to confirm the reliability of this process before proceeding with further studies. They are recruiting participants without any past or current psychiatric issues or major medical problems and who have not used medications for mental health. The trial includes only one treatment group with [18F]-FTC-146. Participants should be generally healthy and able to undergo MRI scans. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new radiotracer.

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

The trial does not specify if you need to stop taking your current medications, but it excludes anyone who has used psychotropic medication (drugs affecting the mind) in the past or currently.

Is there any evidence suggesting that [18F]-FTC-146 is likely to be safe for humans?

Research has shown that [18F]-FTC-146 has been well-tolerated in studies so far. Participants in various studies reported no negative reactions during or after PET/MRI scans. For instance, one study observed no side effects on the day of the scan or during a week-long follow-up. Another study with ten healthy volunteers also found no adverse reactions.

These results suggest that [18F]-FTC-146 is generally safe for humans based on the data collected so far. However, since this is an early-phase trial, researchers continue to closely monitor the treatment for any possible side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [18F]-FTC-146 because it offers a new way to image the sigma-1 receptor, which is involved in several neurological conditions. Unlike current imaging agents, [18F]-FTC-146 is designed to specifically target this receptor, potentially providing clearer and more accurate images. This could lead to better diagnosis and understanding of diseases like Alzheimer's and neuropathic pain, making it a promising tool in neurological research.

What evidence suggests that [18F]-FTC-146 is effective for brain imaging?

Research has shown that [18F]-FTC-146, which participants in this trial will receive, is promising due to its safety and effective distribution throughout the body. Early human studies found it to be safe with acceptable radiation levels. This treatment targets the s-1 receptor, aiding in understanding brain absorption. Initial tests using PET/MRI scans demonstrated its potential in healthy individuals by mapping its path in the body. Although still in the early stages, the safety and distribution data support further research on [18F]-FTC-146 in clinical settings. ^{1 2 3 6 7}

Who Is on the Research Team?

Carolyn Rodriguez, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged 18-65, capable of giving informed consent. Participants can be of any gender or ethnicity but must use effective birth control if female. Those with a history of psychiatric diagnoses, major medical or neurological issues, metal implants not suitable for MRI scans, or who are pregnant/nursing cannot join.

Inclusion Criteria

Female participants are expected to use an effective method of birth control throughout the study

My gender and ethnicity do not limit my participation.

I understand and can agree to the study's procedures and risks.

Exclusion Criteria

Any current or lifetime psychiatric diagnosis

Current or past use of psychotropic medication

Pregnant or nursing females

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Test

Participants undergo initial brain uptake testing with [18F]-FTC-146

1 week

1 visit (in-person)

Retest

Participants undergo retest for brain uptake with [18F]-FTC-146 to assess reliability

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [18F]-FTC-146

Trial Overview [18F]-FTC-146's reliability in brain uptake is being tested in this study. The goal is to understand how consistently the substance accumulates in the brains of healthy people without influencing factors like medication or existing health conditions.

How Is the Trial Designed?

Group I: [18F]-FTC-146 Experimental Treatment 1 Intervention

\[18F\]-FTC-146

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6944163/

Biodistribution and Radiation Dosimetry of 18F-FTC-146 in ... Conclusion: First-in-human studies with clinical-grade 18F-FTC-146 were successful. Injection of 18F-FTC-146 is safe, and absorbed doses are acceptable. The ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03649555

Reliability of [18F]-FTC-146 Brain Uptake in Healthy Controls It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/jnumed/58/12/2004.full.pdf

Biodistribution and Radiation Dosimetry of 18F-FTC-146 in ... The purpose of this study was to assess safety, biodistribution, and radiation dosimetry in humans for the highly selective s-1 receptor.

4. researchgate.net researchgate.net/publication/314486741_Radiosynthesis_and_First-In-Human_PETMRI_Evaluation_with_Clinical-Grade_18FFTC-146

Radiosynthesis and First-In-Human PET/MRI Evaluation ... The safety and whole body biodistribution of [(18)F]FTC-146 were evaluated using a simultaneous PET/MR scanner in two representative healthy human subjects.

5. ejnmmires.springeropen.com ejnmmires.springeropen.com/articles/10.1186/s13550-015-0122-2

Further validation to support clinical translation of [18F]FTC ... This study aims to further evaluate the specificity and selectivity of [18F]FTC-146 and obtain additional data to support its clinical ...

6. withpower.com withpower.com/trial/phase-1-chronic-pain-6-2018-1c6d0

PET/MRI with [18F]FTC-146 for Chronic Pain In a study with ten healthy volunteers, [18F]FTC-146 was found to be safe, with no adverse reactions reported during PET/MRI examinations. Show more.

7. researchgate.net researchgate.net/publication/282042843_Further_validation_to_support_clinical_translation_of_18FFTC-146_for_imaging_sigma-1_receptors

Further validation to support clinical translation of [(18)F ... The safety and whole body biodistribution of [(18)F]FTC-146 were evaluated using a simultaneous PET/MR scanner in two representative healthy ...