FolateScan in Autoimmune Disease

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. Read our disclaimer for details. Identifier: NCT00588393
Recruitment Status : Completed
First Posted : January 8, 2008
Last Update Posted : April 16, 2010
Information provided by:
Mayo Clinic

December 22, 2007
January 8, 2008
April 16, 2010
September 2006
December 2007   (Final data collection date for primary outcome measure)
detection of joint inflammation due to active rheumatoid arthritis [ Time Frame: 1 hour post injection of 0.1 mg of EC20 ]
Same as current
Complete list of historical versions of study NCT00588393 on Archive Site
detection of systemic organ inflammation due to rheumatoid arthritis [ Time Frame: 1 hour post injection of 0.1mg of EC20 ]
Same as current
Not Provided
Not Provided
FolateScan in Autoimmune Disease
Study of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory Diseases
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.

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.

Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Rheumatoid Arthritis
  • Osteoarthritis
  • Multiple Sclerosis
  • Crohn's Disease
  • Systemic Lupus Erythematosus
Drug: FolateScan (Technetium Tc 99mEC20)
0.1 mg. of EC20 labeled with 20-25 mCi of technetium-99m followed by FolateScan
Not Provided
Xia W, Hilgenbrink AR, Matteson EL, Lockwood MB, Cheng JX, Low PS. A functional folate receptor is induced during macrophage activation and can be used to target drugs to activated macrophages. Blood. 2009 Jan 8;113(2):438-46. doi: 10.1182/blood-2008-04-150789. Epub 2008 Oct 24.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2007
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Study will include 40 subjects with rheumatoid arthritis (active or inactive disease, defined as no swollen joints) and 5 patients in each of the following diagnosis: osteoarthritis, multiple sclerosis, Crohn's disease, systemic lupus erythematosus, interstitial lung disease and no autoimmune disease (healthy).
  • Subjects must have disease duration of at least 6 months and creatinine level may not be greater than 1.5 mg/dL.

Exclusion Criteria:

  • Subjects will be excluded if they are pregnant, have an active infection, received an investigational therapy in the past month or previous malignancy within the past 5 years.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Eric L. Matteson, M.D., M.P. H., Mayo Clinic
Mayo Clinic
Principal Investigator: Eric L Matteson, M.D., M.P.H. Mayo Clinic
Mayo Clinic
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP