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Protocol Details

Evaluation of a Novel PET Radioligand as an Inflammatory Biomarker in Musculoskeletal Conditions

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


PET Imaging

Recruitment Keyword(s)



Rheumatoid Arthritis;
Healthy Volunteers

Investigational Drug(s)


Investigational Device(s)



Diagnostic Test: 11C-MC1
Drug: Celecoxib

Supporting Site

National Institute of Mental Health


Inflammation can play a role in diseases like heart disease and rheumatoid arthritis. PET scans can help detect inflammation. Two new drugs may create better PET images.


To see if the drugs [11C]ER176 and [11C]MC1 can help image inflammation.


People ages 18 and older with rheumatoid arthritis or idiopathic inflammatory myopathy (IIM).

Healthy volunteers enrolled in protocol 01-M-0254 or 17-M-0181 are also needed.


Healthy participants will be screened under protocol 01-M-0254 or 17-M-0181.

Participants with arthritis or IIM will have a screening visit. This will include:

Medical history

Physical exam

Blood and urine tests

Possible CT or X-ray: A machine will take pictures of the body.

Healthy participants will have 1 or 2 visits. They may have urine tests. They may take the drug celecoxib by mouth. They will have a PET scan. A small amount of one or both study drugs will be injected through a catheter: A needle will guide a thin plastic tube into an arm vein. Another catheter will draw blood. They will like on a bed that slides into a machine. Their vital signs and heart activity will be measured.

Participants with arthritis will have up to 2 visits after screening. They may take celecoxib and have PET scans.

Participants with IIM will have up to 3 visits after screening. At 1 or 2 visits, they will take celecoxib and have PET scans. They will have 1 visit where they have an MRI: They will lie on a table that slides into a machine. The machine takes pictures of the body.

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1) Healthy subjects

-Age greater than or equal to 18.

-Willing and able to complete all study procedures.

-Able to give written informed consent.

-Medically healthy.

-Enrolled in protocol #01M0254 "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".

-Be age-, sex-, and genotype-matched with patient groups for the 15 subjects in the Phase 2.

-If female, no plans for pregnancy within the ensuing 3 months in the Phase 2.

2) RA patients

-Age greater than or equal to 18.

-Willing and able to complete all study procedures.

-Able to give written informed consent.

-Have been given a diagnosis of RA based on the published criteria

-Have moderate to severe symptoms, as defined by a DAS28-ESR score >3.2, but RA patients may be in remission for the repeat scan in phase 4.

-If female, no plans for pregnancy within the ensuing 3 months for studies using celecoxib and for five months for the longitudinal study (Phase 4).

3) IIM patients

-Age greater than or equal to 18.

-Willing and able to complete all study procedures.

-Able to give written informed consent.

-Meets Bohan and Peter criteria for probable or definite DM or PM, or

-Meets criteria for IBM as defined by Lloyd et al. : 1) finger flexor or quadriceps weakness, and 2) endomysial inflammation, and

3) either invasion of non-necrotic muscle fibers or rimmed vacuoles.

-If female, no plans for pregnancy within the ensuing 3 months.


1) Common for all participants

-Because non-steroidal anti-inflammatory drugs (NSAIDs) inhibit COX-2, subjects should not have taken NSAIDs or willow bark tea for two weeks prior to the PET scan.

-For Phase 2, 3 and 4 *contraindications to taking COX-2 inhibitors include:

--History of hypersensitivity reaction to COX inhibitors or History of aspirin- or NSAID-induced asthma;

--History of upper or lower gastrointestinal bleeding, gastritis, peptic ulcer disease;

--History of uncontrolled gastroesophageal reflux disease (GERD), but not medically-controlled GERD;

--Coagulation disorder;


--G6PD deficiency;

--History of gout;

--History of hepatic or renal impairment;

--History of cardiovascular disease or presence of cardiovascular risk factors such as uncontrolled or poorlycontrolled hypertension.

--Current use of probenecid

--Patients clinically in remission or who have low disease activity

-Positive HIV test.

-Any other history of severe medical illness or injury with the potential to affect study data interpretation or to be any medical contraindication to the procedures performed in the study, including active infection and untreated malignancy.

-Unable to travel to NIH

-Recent exposure to radiation related to research (e.g., 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, including claustrophobia and overweight greater than the maximum for the scanner (500 lb).

-Current 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 affects the function of daily life.

-NIMH employees and staff or immediate family member of NIMH employee/staff.

*These criteria will not be applied to the two healthy volunteers participating in the Phase 1 of this study.

2) Healthy subjects

-Clinically significant laboratory abnormalities based on tests performed under screening protocol 01-M-0254 or 17-M-0181.

3) IIM patients

-Unable to have an MRI scan (e.g., pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, or shrapnel fragments, metal fragments in the eye).

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Ikawa M, Lohith TG, Shrestha S, Telu S, Zoghbi SS, Castellano S, Taliani S, Da Settimo F, Fujita M, Pike VW, Innis RB; Biomarkers Consortium Radioligand Project Team. 11C-ER176, a Radioligand for 18-kDa Translocator Protein, Has Adequate Sensitivity to Robustly Image All Three Affinity Genotypes in Human Brain. J Nucl Med. 2017 Feb;58(2):320-325. doi: 10.2967/jnumed.116.178996. Epub 2016 Nov 17.

Kreisl WC, Jenko KJ, Hines CS, Lyoo CH, Corona W, Morse CL, Zoghbi SS, Hyde T, Kleinman JE, Pike VW, McMahon FJ, Innis RB; Biomarkers Consortium PET Radioligand Project Team. A genetic polymorphism for translocator protein 18 kDa affects both in vitro and in vivo radioligand binding in human brain to this putative biomarker of neuroinflammation. J Cereb Blood Flow Metab. 2013 Jan;33(1):53-8. doi: 10.1038/jcbfm.2012.131. Epub 2012 Sep 12.

van der Laken CJ, Elzinga EH, Kropholler MA, Molthoff CF, van der Heijden JW, Maruyama K, Boellaard R, Dijkmans BA, Lammertsma AA, Voskuyl AE. Noninvasive imaging of macrophages in rheumatoid synovitis using 11C-(R)-PK11195 and positron emission tomography. Arthritis Rheum. 2008 Nov;58(11):3350-5. doi: 10.1002/art.23955.

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Principal Investigator

Referral Contact

For more information:

Robert B. Innis, M.D.
National Institute of Mental Health (NIMH)
(301) 594-1368

Tara N. Turon, C.R.N.P.
National Institute of Mental Health (NIMH)
(301) 827-6599

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

Clinical Trials Number:


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