Novel PET Radioligand as an Inflammatory Biomarker in Musculoskeletal Conditions

Summary

Background:

Inflammation plays a significant role in various disorders that involve neurodegeneration or autoimmune reaction as one of their mechanisms. PET scans can help detect inflammation. Two new drugs may create better PET images.

Objective:

\- To see if the drug \[11C\]MC1 can help image inflammation.

Eligibility:

* People age 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.

Conditions

• Myositis
• Inflammatory
• Rheumatoid Arthritis
• Healthy Volunteers

Interventions

DRUG

11C-MC1

PET radioligand for Cyclooxygenase-2 (COX-2)

DRUG

Celecoxib

Cyclooxygenase-2 (COX-2) inhibitor

DRUG

[11C]ER176

Radioligand for 18-kDa Translocator Protein

DIAGNOSTIC_TEST

Positron Emission Tomography (PET)/computed tomography (CT) Scan

Whole body or brain PET/CT scans

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  lead NIH

Principal Investigators

• Robert B Innis, M.D. · National Institute of Mental Health (NIMH)

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-14

Primary Completion

2024-06-14

Completion

2024-06-14

FDA Drug

Yes

Countries

• United States

Study Locations