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

April 10, 2023 updated by: Carolyn Rodriguez, Stanford University
The purpose of this study is to understand the reliability of [18F]-FTC-146 brain uptake in healthy controls.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 (Anticipated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

October 1, 2024

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 (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Controls

Clinical Trials on [18F]-FTC-146

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe