Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03912428|
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : October 30, 2020
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:
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.
|Condition or disease||Intervention/treatment||Phase|
|Myositis||Drug: Celecoxib Diagnostic Test: 11C-MC1 Diagnostic Test: 11C-ER176||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis|
|Actual Study Start Date :||June 14, 2019|
|Estimated Primary Completion Date :||February 22, 2022|
|Estimated Study Completion Date :||February 22, 2023|
all groups get the same studies
Diagnostic Test: 11C-MC1
PET radioligand for COX-2
Diagnostic Test: 11C-ER176
PET radioligand for TSPO
- Uptake of the radioligands in the affected body area [ Time Frame: 2 hours ]Radioligand uptake in a selected region of interest will be quantified as a Standardized Uptake Value (SUV), which normalizes for injected activity and body weight. Possible differences in actual blood radioligand level will be adjusted by venous blood data obtained during the PET scan. Regional uptake after blockade with celecoxib will be expressed as a percentage of the baseline value. The baseline uptake and the percentage blockade by celecoxib of each radioligand will be compared between patients and healthy subjects as well as between inflamed and non-inflamed regions of the body in RA and IIM patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912428
|Contact: Maria D Ferraris Araneta, C.R.N.P.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Robert B Innis, M.D.||National Institute of Mental Health (NIMH)|