FolateScan in Autoimmune Disease
|Rheumatoid Arthritis Osteoarthritis Multiple Sclerosis Crohn's Disease Systemic Lupus Erythematosus||Drug: FolateScan (Technetium Tc 99mEC20)||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Study of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory Diseases|
- detection of joint inflammation due to active rheumatoid arthritis [ Time Frame: 1 hour post injection of 0.1 mg of EC20 ]
- detection of systemic organ inflammation due to rheumatoid arthritis [ Time Frame: 1 hour post injection of 0.1mg of EC20 ]
|Study Start Date:||September 2006|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Drug: FolateScan (Technetium Tc 99mEC20)
The folate receptor is over-expressed on many types of cancer cells and in RA models, and new folate receptor targeted therapies are being developed to target cancer cells that over-express the folate receptor. As with other targeted therapies, it is important to develop diagnostic tests that will provide accurate information on folate receptor status and aid in selecting patients that may benefit from folate-targeted therapy.
EC20 concentrates in the extremities and liver and spleen of rats with adjuvant induced arthritis. The increased uptake is mediated by overexpressed folate receptor on macrophages, and the intensity of the uptake is greatly reduced by addition of excess folate, supporting the specificity of the uptake. Depletion of macrophages greatly reduced folate receptor and abolishes uptake of EC20. This suggests that EC20 may be useful in assessing macrophage involvement in the active inflammatory process of RA, and perhaps other systemic immune mediated disorders as well.
FolateScan may allow the clinician to get accurate real-time data on receptor binding, in a less invasive manner, at all actively inflamed sites throughout the treatment regimen. This kind of information may help the physician make better clinical decisions regarding therapy, including folate targeted therapies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588393
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Eric L Matteson, M.D., M.P.H.||Mayo Clinic|