[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

6 Participants Needed

Trial Summary

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 [18F]-FTC-146 safe for use in humans?

In a study with ten healthy volunteers, [18F]-FTC-146 was found to be safe, with no adverse reactions reported. The absorbed radiation doses were within acceptable limits, indicating it is generally safe for human use. ^{1 2 3 4 5}

How is the [18F]-FTC-146 imaging treatment different from other treatments?

The [18F]-FTC-146 imaging treatment is unique because it involves using a radioactive tracer for imaging purposes, rather than treating a condition directly. This approach is different from standard treatments as it focuses on visualizing and studying the brain's structure and function in healthy individuals, rather than providing therapeutic effects. ^{6 7 8 9 10}

What is the purpose of this trial?

The purpose of this study is to understand the reliability of \[18F\]-FTC-146 brain uptake in healthy controls.

Research Team

Carolyn Rodriguez, MD, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Biodistribution and Radiation Dosimetry of 18F-FTC-146 in Humans. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of the biodistribution and radiation dosimetry of the 18F-labelled amyloid imaging probe [18F]FACT in humans. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, metabolism, biodistribution, radiation dosimetry, and toxicology of (18)F-fluoroacetate ((18)F-FACE) in non-human primates. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Radiation dosimetry estimates of [18F]-fluoroacetate based on biodistribution data of rats. [2012]

5. England pubmed.ncbi.nlm.nih.gov

Preclinical dosimetry models and the prediction of clinical doses of novel positron emission tomography radiotracers. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Prevalence of abnormal findings in 230 knees of asymptomatic adults using 3.0 T MRI. [2021]

7. Poland pubmed.ncbi.nlm.nih.gov

Whole-Body MRI Screening in Asymptomatic Subjects; Preliminary Experience and Long-Term Follow-Up Findings. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

CERMEP-IDB-MRXFDG: a database of 37 normal adult human brain [18F]FDG PET, T1 and FLAIR MRI, and CT images available for research. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Whole-body magnetic resonance imaging of healthy volunteers: pilot study results from the population-based SHIP study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Prevalence, distribution, and morphology of ossification of the ligamentum flavum: a population study of one thousand seven hundred thirty-six magnetic resonance imaging scans. [2022]