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Assessment of [11C]ER176 to Image Translocator Protein in Brain and Whole Body of Healthy People

NCT02147392 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-07-05

No results posted yet for this study

Summary

Background:

\- A protein called translocator protein may play a role in brain inflammation. Sometimes it is present at higher levels in the lungs than in the brain. Researchers want to see if a drug called \[11C\]ER176 can provide an image of this protein in the brain.

Objective:

\- To test the ability of a drug to image a protein, and test how it is distributed in the body.

Eligibility:

\- Healthy adults over age 18.

Design:

* Participants will be screened with medical history, physical exam, and blood and urine tests.
* Participants will have a PET scan of the brain using \[11C\]ER176. It will be injected through an intravenous tube into 1-2 arm veins. A tube may also be put into an artery at the wrist or elbow. Some participants will also have a lung scan.
* For the PET, participants will lie on a bed that slides in and out of a doughnut-shaped scanner. A plastic mask will be molded to their face and head. They may be wrapped with restraining sheets. The scan will last about 120 minutes. Blood may be taken during the scan.
* Blood and urine will be taken before and after the scan.
* During another visit, participants will have an MRI scan of the brain. Participants will lie on a table that slides in and out of a metal cylinder. A strong magnetic field and radio waves will take pictures of the brain. The scanner makes loud knocking noises. Participants will be given earplugs.
* Some participants will have only a whole-body PET scan using \[11C\]ER176.

Conditions

  • Pharmacokinetics
  • Adult

Interventions

DRUG

[11C]ER-176

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Robert B Innis, M.D. · National Institute of Mental Health (NIMH)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-14
Primary Completion
2016-06-16
Completion
2016-06-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02147392 on ClinicalTrials.gov