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

NCT ID: NCT03649555

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-03-03

Brief Summary

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

Detailed Description

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

Conditions

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Healthy Controls

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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[18F]-FTC-146

\[18F\]-FTC-146

Group Type EXPERIMENTAL

[18F]-FTC-146

Intervention Type 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.

Interventions

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[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.

Intervention Type DRUG

Other Intervention Names

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Sigma-1 receptor radioligand

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Carolyn Rodriguez

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carolyn Rodriguez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Department of Psychiatry and Behavioral Sciences

Stanford, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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45678

Identifier Type: -

Identifier Source: org_study_id

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