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

NCT03324646 | Completed FDA Drug

• 2 other identifiers: 17017917-M-0179
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Normal Physiology

Keywords

Research; Brain; Inflammation; Natural History

Outcome Measures

Primary Outcomes (1)

• PET tracer update

  For whole body imaging, organ uptake will be quantified as a Standardized Uptake Value (SUV), which normalizes for injected activity and body weight. Blockade by aspirin, ketoprofen, and celecoxib will be expressed as a percentage of the baseline scan in each subject and plotted relative to the plasma concentration of the drug at time of the PET scan. For dedicated brain imaging, uptake will be quantified as distribution volume (VT) calculated with compartmental modeling and serial concentrations of parent radioligand in arterial and/or venous plasma.

  during PET scan

Study Arms (1)

controls

healthy subjects

Drug: [11C]PS13

Interventions

[11C]PS13 DRUG

A novel PET ligand to selectively image COX-1

controls

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• 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".

You may not qualify if:

• 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
• Current use of psychiatric medications.
• NIMH employees and staff or an NIH employee who is a subordinate/relative/co-worker of the investigators.
• 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).

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Kim MJ, Lee JH, Juarez Anaya F, Hong J, Miller W, Telu S, Singh P, Cortes MY, Henry K, Tye GL, Frankland MP, Montero Santamaria JA, Liow JS, Zoghbi SS, Fujita M, Pike VW, Innis RB. First-in-human evaluation of [11C]PS13, a novel PET radioligand, to quantify cyclooxygenase-1 in the brain. Eur J Nucl Med Mol Imaging. 2020 Dec;47(13):3143-3151. doi: 10.1007/s00259-020-04855-2. Epub 2020 May 12.

  PMID: 32399622 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Inflammation

Interventions

11C-PS13

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert B Innis, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: October 30, 2017
• Study Start: October 3, 2017
• Primary Completion: September 11, 2020
• Study Completion: January 30, 2024
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

US (1)