(18F)FCWAY and the Blood-Brain Barrier

Completed

Conditions studied: Drug Resistance

In brief

Background: \- The blood-brain barrier helps protect the brain from infections and toxins in the blood stream. But it can also prevent certain drugs from reaching the brain to treat diseases or other problems. Researchers are interested in chemicals that will help show how the barrier works. One possible chemical, (18F)FCWAY, may be useful for studying the barrier. More tests are needed to determine how effective it is. Objectives: \- To test whether (18F)FCWAY can be used to help study the blood-brain barrier. Eligibility: \- Healthy volunteers between 18 and 50 years of age. Design: * This study requires a screening visit and two scanning visits. * Participants will be screened with a physical exam and medical history. They will also have blood and urine tests. * At the first scanning visit, participants will have a magnetic resonance imaging scan to provide baseline images of the brain. * Before the second visit, some participants will stay overnight in the hospital. They will receive the drug tariquidar, which may help the (18F)FCWAY show the blood-brain barrier more clearly. * At the second scanning visit, all participants will have a positron emission tomography scan with (18F)FCWAY to see how well the drug shows the blood-brain barrier on the scan.

Key facts

Study ID

NCT01386476

Run by

National Institute of Mental Health (NIMH)

People needed

18

Starts

2011-06-15

Expected to finish

2016-09-01

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Subjects routinely taking prescription medications, except birth control pills. That is, subjects should not discontinue mediations merely to participate in this study.
• Subjects taking recreational or over-the-counter drugs.
• Subjects will be excluded if they have any current Axis I diagnosis, including a current diagnosis of alcohol or substance abuse.
• History of psychotic symptoms or suicide attempt.
• Head trauma resulting in a period of unconsciousness lasting longer than 10 minutes or a history of seizures, because seizures may increase the function of P-gp.
• Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
• Pregnancy or breast feeding.
• Positive urine drug screen.
• Unlikely to tolerate small, enclosed spaces, as in the MRI.
• Metallic foreign bodies that would be affected by the MRI magnet or fear of enclosed spaces likely to make the subject unable to complete an MRI scan.
• Positive HIV status.
• Inability to lie flat on camera bed for about 2 (Omega) hours.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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