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

Healthy Controls Clinical Trial

— rSIG  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03649555
• Other study ID #: 45678
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 1, 2019
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Controls

Intervention

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.

Locations

Country	Name	City	State
United States	Department of Psychiatry and Behavioral Sciences	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Rodriguez Lab Website