Reliability of [18F]-FTC-146 Brain Uptake in Healthy Controls

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

Completed

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Key information

Conditions

Healthy Controls

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Psychiatry and Behavioral Sciences

Stanford, California, 94304, United States

About this study

The purpose of this study is to understand the reliability of [18F]-FTC-146 brain uptake in healthy controls under test and retest conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ages 18-65
either gender and all ethno-racial categories
capacity to provide informed consent
Female participants are expected to use an effective method of birth control throughout the study

Exclusion criteria

Any current or lifetime psychiatric diagnosis
Current or past use of psychotropic medication
Pregnant or nursing females
Major medical or neurological problem
Presence of metal in the body that is contraindicated for MRI scans

Treatment and study plan

[18F]-FTC-146

Drug

Two 5 mCi [18F]-FTC-146 doses will be administered intravenously on two separate scan days at least one week apart (total per study = 10 mCi) Participants who complete both test days will receive 10 mCi total dose; however, if a participant is unable to return for a second test day due to unforeseen circumstances, they will receive 5 mCi total dose.

Other names: Sigma-1 receptor radioligand

Primary outcomes

Reliability under test retest conditions

Time frame: 1 week

Regional brain uptake of [18F]FTC-146 will be analyzed by kinetic modeling with metabolite-corrected arterial input functions to establish stability and reproducibility of [18F] FTC-146 VT in humans (n=6) under test and retest conditions.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: rSIG

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2021
First posted: Aug 28, 2018
Registry last updated: Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed