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Protocol Details

Evaluation of a Novel PET Radioligand to Image Cyclooxygenase-1 (COX-1)

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-M-0179

Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

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

Referral Letter Required

No

Population Exclusion(s)

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

Keywords

Research;
Brain;
Inflammation;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Normal Physiology

Investigational Drug(s)

11C-PS13

Investigational Device(s)

None

Intervention(s)

Drug: [11C]PS13

Supporting Site

National Institute of Mental Health

Background:

A radioligand is a radioactive substance that is used to diagnose diseases. A new ligand is called [11C]PS13. This has a small amount of radioactivity that can be detected by a positron emission tomography (PET) scan. If this ligand works well in this study, researchers may be able to use it to better understand and diagnose brain disorders.

Objectives:

To evaluate if [11C]PS13 can measure its receptor, which is involved in inflammation. To see if researchers get the same results when scanning a person twice.

Eligibility:

Healthy people ages 18 and older who are in Protocol 01-M-0254.

Design:

This study requires three visits of 2-5 hours each.

Participants will have 2 PET scans with [11C]PS13.

A needle will guide a small plastic tube (catheter) into an arm vein. The needle will be removed, leaving only the catheter in the vein. The ligand will be injected through the catheter.

The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner.

Participants will wear a molded a plastic mask that fits the head.

Another catheter will be put into an artery at the wrist or elbow area.

Vital signs will be monitored during the PET scan. Participants will have a test during the PET scan to monitor heart function.

Participants will have blood and urine tests.

Participants will have 1 magnetic resonance imaging (MRI) scan. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder.

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Eligibility

INCLUSION CRITERIA:

- Aged 18 years or older.

-Able to provide informed consent.

-Medically and psychiatrically healthy.

-Enrolled in 01-M-0254 The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17-M-0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies".

EXCLUSION CRITERIA All phases

-Because non-steroidal anti-inflammatory drugs (NSAIDs) inhibit COX-1 and/or COX-2, subjects should not have taken NSAIDs for two weeks prior to the PET scan. In addition, aspirin must not have been taken in the prior month, as aspirin irreversibly inhibits COX.

-Clinically significant laboratory abnormalities based on tests performed under screening protocol 01-M-0254 or 17-M-0181 and specified in Section 4.c Screening.

-Any current Axis I diagnosis, based on interview and self-reporting performed under screening protocol 01-M-0254 or 17-M-0181.

-HIV infection.

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

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

-Inability to lie flat on camera bed for at least two hours.

-Pregnancy or breastfeeding.

-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 impairs function of daily life..

-Current use of psychiatric medications.

-NIMH employees and staff or an NIH employee who is a subordinate/relative/co-worker of the investigators.

EXCLUSION CRITERIA Phase 2:

-Because aspirin and celecoxib require an acidic environment to be absorbed in the stomach, we will exclude those who have taken proton pump inhibitor (PPI) drugs, H-2 receptor antagonist drugs, and antacid drugs in the last two weeks.

-additional contraindications to taking COX-1 or COX-2 inhibitors include:

--history of hypersensitivity reaction to COX inhibitors history of aspirin- or NSAID-induced asthma.

--history of upper or lower gastrointestinal bleeding, gastritis, peptic ulcer disease, or gastroesophageal reflux disease (GERD).

--coagulation disorder.

--thrombocytopenia.

--G6PD deficiency.

--history of gout.

--history of hepatic or renal impairment.

--history of cardiovascular disease or presence of cardiovascular risk factors such as hypertension.

EXCLUSION CRITERIA Phase 3:

-Artery check for art line

-Unable to have an MRI scan

NIH employees are eligible to participate. NIMH employee participation is guided by intramural institute policy.


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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:

NCT03324646

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