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Protocol Details

Assessment of [18F]SF12051 for Imaging the 18-kDa Translocator Protein (TSPO) in Brain and Whole Body of Healthy Subjects

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000674-M

Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years

Referral Letter Required

No

Population Exclusion(s)

Fetuses;
Neonates;
Pregnant Women;
Adults who are or may become unable to consent;
Children

Keywords

PET Imaging;
Neuroinflammation;
Tspo

Recruitment Keyword(s)

None

Condition(s)

Healthy

Investigational Drug(s)

18F SF12051

Investigational Device(s)

None

Intervention(s)

Drug: 18F-SF12051

Supporting Site

National Institute of Mental Health

Background:

Inflammation in the brain plays a role in many diseases. Being able to measure inflammation in a person s brain might help to diagnose and treat these diseases. One protein (TSPO) appears in higher numbers when inflammation affects the brain. To see TSPO when a person s body is scanned, researchers need a substance called a radiotracer that will attach to this protein and no other molecules.

Objective:

This study will test whether a new radiotracer ([18F]SF12051) can make TSPO appear on PET scans of a person s brain and body.

Eligibility:

Healthy people aged 18 and older.

Design:

This study requires 2 to 4 visits to the clinic.

All participants will be screened. They will have a physical exam. They will have blood tests and a test of their heart function.

Some participants will have a positron emission tomography (PET) scan of the whole body. The radiotracer will be injected through a tube (catheter) placed in a vein in the arm. The PET scanner is a machine shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. The scan will take about 2 hours.

Some participants will have a PET scan of just their head. After they are injected with the radiotracer, they will lie on a bed with their head in the scanner. Blood will be drawn from a catheter in the wrist during the scan.

Some participants will have a magnetic resonance imaging (MRI) scan of the brain. They will lie on a narrow bed that slides into a tube.

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Eligibility

INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all of the following criteria:

- Aged 18 years or older.

- Healthy based on medical history, physical examination, and laboratory testing.

- Able to provide informed consent.

- Willing and able to complete all study procedures.

- Have been screened for TSPO genotype under 01-M-0254 "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants".

- Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists*.

- Agree to adhere to the lifestyle considerations

*Does not apply to Phase 1 and 3 participants as they will not have an arterial line.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

- Clinically significant abnormalities on EKG or laboratory testing. This includes CBC; acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen); hepatic panel (alkaline phosphatase, ALT, AST, bilirubin total, and bilirubin direct); mineral panel (albumin, calcium, magnesium, phosphorus); prothrombin and partial prothrombin tests.

- Participants should not have taken NSAIDs or willow bark tea for two weeks prior to the PET scan.

- Any current Axis I diagnosis.

- Positive test for HIV.

- Unable to have an MRI scan*.

- History of neurologic illness or injury with the potential to affect study data interpretation.

- History of seizures, other than in childhood and related to fever.

- Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.

- Inability to lie flat on camera bed for at least two hours, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).

- Pregnancy or breast feeding.

- Able to get pregnant but does not use birth control.

- Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use affects the function of daily life.

- Unable to travel to NIH.

- National Institute of Mental Health (NIMH) staff or an NIH employee who is a subordinate/relative/co-worker of the investigators.

*Phase 1 and 3 participants will not get an MRI.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Robert B. Innis, M.D.
National Institute of Mental Health (NIMH)
NIHBC 10 - CLINICAL CENTER BG RM B1D43J
10 CENTER DR
BETHESDA MD 20892
(301) 594-1368
robert.innis@nih.gov

Tara N. Turon, C.R.N.P.
National Institute of Mental Health (NIMH)
NIHBC 10 - CLINICAL CENTER BG RM B1D43G
10 CENTER DR
BETHESDA MD 20892
(301) 827-6599
tara.turon@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05564429

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