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

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

Study Overview

• Status: Completed
• Conditions: Healthy Controls
• Intervention / Treatment: Drug: [18F]-FTC-146

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Department of Psychiatry and Behavioral Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: [18F]-FTC-146

Drug: [18F]-FTC-146; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability under test retest conditions	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.	1 week

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Carolyn Rodriguez, MD, PhD, Stanford University

Publications and helpful links

Helpful Links

• Rodriguez Lab Website

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): March 3, 2020
• Study Completion (Actual): March 3, 2021

Study Registration Dates

• First Submitted: August 25, 2018
• First Submitted That Met QC Criteria: August 25, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 6-(3-fluoropropyl)-3-(2-(azepan-1-yl)ethyl)benzo(d)thiazol-2(3H)-one
• Other Study ID Numbers: 45678

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No