This study is currently recruiting participants.
Number
19-M-0079
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
Yes
Population Exclusion(s)
Fetuses;Neonates;Pregnant Women;Children
Keywords
Inflammatory; PET Imaging
Recruitment Keyword(s)
None
Condition(s)
Myositis; Inflammatory; Rheumatoid Arthritis; Healthy Volunteers
Investigational Drug(s)
11C-MC1
Investigational Device(s)
Intervention(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.
Objective:
To see if the drugs [11C]ER176 and [11C]MC1 can help image inflammation.
Eligibility:
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.
Design:
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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INCLUSION CRITERIA: 1) Healthy subjects -Aged 18 years or older. -Willing and able to complete all study procedures. -Able to provide informed consent. -Healthy based on medical history, physical examination, and laboratory testing. -Enrolled in protocol 01M0254 The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17M0181 Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies . -Be age-, and sex-matched with patient groups for the 15 subjects in the Phase 2. 2) RA patients -Aged 18 years or older. -Willing and able to complete all study procedures. -Able to provide 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. 3) IIM patients -Aged 18 years or older -Willing and able to complete all study procedures. -Able to provide 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. 4) AxSpA patients -Aged 18 years or older. -Willing and able to complete all study procedures. -Able to provide informed consent. -Have been given a diagnosis of AxSpA based on Assessment of Spondylo-Arthritis International Society (ASAS) criteria AxSpA. EXCLUSION CRITIERIA: 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 that, in the opinion of the investigators, have the potential to affect the results or the safety of the participant. These may 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; --Thrombocytopenia; --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 infection. -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). -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 or an NIH employee who is a subordinate/relative/co-worker of the investigators. *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) AxSpA and 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).
1) Healthy subjects
-Aged 18 years or older.
-Willing and able to complete all study procedures.
-Able to provide informed consent.
-Healthy based on medical history, physical examination, and laboratory testing.
-Enrolled in protocol 01M0254 The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17M0181 Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies .
-Be age-, and sex-matched with patient groups for the 15 subjects in the Phase 2.
2) RA patients
-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.
3) IIM patients
-Aged 18 years or older
-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.
4) AxSpA patients
-Have been given a diagnosis of AxSpA based on Assessment of Spondylo-Arthritis International Society (ASAS) criteria AxSpA.
EXCLUSION CRITIERIA:
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 that, in the opinion of the investigators, have the potential to affect the results or the safety of the participant.
These may 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;
--Thrombocytopenia;
--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 infection.
-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).
-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 or an NIH employee who is a subordinate/relative/co-worker of the investigators.
*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) AxSpA and 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).
Principal Investigator
Referral Contact
For more information: