A Study of FolateScan in Patients With Knee Osteoarthritis

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate 99mTc - EC20 imaging (FolateScan), a Nuclear Medicine imaging technology that enables localization of activated macrophages in the joints of participants with knee osteoarthritis (OA). Twenty five participants with symptomatic unilateral or bilateral knee OA will undergo a one-time evaluation of the knee as follows: knee radiography, FolateScan of the knees and whole body, musculoskeletal exam, questionnaires, sampling of blood, urine and synovial fluid for analysis of inflammatory markers. Data analysis will be cross-sectional and include a comparison of the location and intensity of EC20 uptake with the following: radiographic knee OA severity, clinical measures of disease severity, cytokine expression, and synovial fluid cell count.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Kraus
• Collaborators: Eli Lilly and Company; Endocyte

Criteria

Inclusion Criteria: Unilateral or bilateral knee OA; Kellgren Lawrence grade 1-4; Knee pain on most days of any one-month in the last year in at least one knee; Age > 18 years old.

Exclusion Criteria: Arthroscopic knee surgery within the previous 12 months; Intra-articular injection or systemic (oral, IV, IM) steroid within previous 6 months; Any knee replacement; Current enrollment in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug used in this study); Pregnancy; Positive serum beta HCG within 48 hours prior to 99mTc-EC20 administration and/or lactation; Rheumatoid arthritis or other inflammatory arthropathy; Avascular necrosis; Periarticular fracture; Current anticoagulant therapy; Current immune modulator therapy, or any such therapy within 4 weeks of study procedures; Inability to discontinue use of NSAIDS within 3 days of study procedures (low dose aspirin of up to 325 mg per day is permitted); Must be able to stop Folic Acid containing vitamins 24 hrs before study; Paget's disease; Villonodular synovitis; Joint infection; Ochronosis; Neuropathic arthropathy; Acromegaly; Hemochromatosis; Wilson's disease; Osteochondromatosis; Personnel directly affiliated with this study or their immediate family members; Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.