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Report for Clinical Trial NCT02147392

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Assessment of [11C]ER-176 to Image Translocator Protein in Brain and Whole-Body of Healthy Subjects

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.

NCT02147392 Pharmacokinetics Adult

1 Interventions

Name: [11C]ER-176

Type: Drug

Primary Outcomes

Measure: The identifiability and time stability of distribution volume calculated with compartmental modeling and evaluate the genotype sensitivity of [11C]ER-176

Time: 1 year

Secondary Outcomes

Measure: Whole-body biodistribution and dosimetry of [11C]ER-176.

Time: 1 year
Purpose: Diagnostic

Allocation: N/A

Single Group Assignment

There is one SNP

SNPs

1 rs6971

Although [(11)C]PBR28 has high in vivo specific signal, it is very sensitive to the high and low affinity states of TSPO, which are caused by the rs6971 single nucleotide polymorphism (SNP) in the fourth exon of the TSPO gene resulting in a nonconservative alanine-to-threonine substitution in position 147 of the encoded TSPO protein.


HPO Nodes