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Sponsors and Collaborators: |
Mayo Clinic Endocyte |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00588393 |
This study will gather information on the safety of FolateScan and the ability of FolateScan to detect inflammation in the joints and other organs in people with arthritis (rheumatoid arthritis and osteoarthritis), systemic lupus erythematosus, multiple sclerosis, interstitial pneumonitis, Crohn's disease as well as in healthy persons without these conditions.
Condition | Intervention | Phase |
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Rheumatoid Arthritis Osteoarthritis Multiple Sclerosis Crohn's Disease Systemic Lupus Erythematosus |
Drug: FolateScan (Technetium Tc 99mEC20) |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Study of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory Diseases |
Estimated Enrollment: | 75 |
Study Start Date: | September 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Mayo Clinic ( Eric L. Matteson, M.D., M.P. H. ) |
Study ID Numbers: | 06-002680 |
Study First Received: | December 22, 2007 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00588393 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Crohn's Disease Osteoarthritis Gastrointestinal Diseases Lupus Arthritis, Rheumatoid Inflammatory Bowel Diseases Ileal Diseases Multiple Sclerosis Musculoskeletal Diseases Lupus Erythematosus, Systemic Arthritis Connective Tissue Diseases Autoimmune Diseases of the Nervous System |
Autoimmune Diseases Demyelinating Diseases Ileitis Joint Diseases Enteritis Sclerosis Rheumatic Diseases Intestinal Diseases Digestive System Diseases Crohn Disease Demyelinating Autoimmune Diseases, CNS Gastroenteritis |
Osteoarthritis Gastrointestinal Diseases Arthritis, Rheumatoid Inflammatory Bowel Diseases Ileal Diseases Pathologic Processes Multiple Sclerosis Musculoskeletal Diseases Lupus Erythematosus, Systemic Arthritis Connective Tissue Diseases Autoimmune Diseases of the Nervous System Autoimmune Diseases |
Immune System Diseases Demyelinating Diseases Ileitis Joint Diseases Enteritis Nervous System Diseases Sclerosis Rheumatic Diseases Intestinal Diseases Digestive System Diseases Crohn Disease Demyelinating Autoimmune Diseases, CNS Gastroenteritis |