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

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Osteoarthritis Multiple Sclerosis Crohn's Disease Systemic Lupus Erythematosus Drug: FolateScan (Technetium Tc 99mEC20) Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Intervention Details:
    Drug: FolateScan (Technetium Tc 99mEC20)
    0.1 mg. of EC20 labeled with 20-25 mCi of technetium-99m followed by FolateScan

Primary Outcome Measures :
  1. detection of joint inflammation due to active rheumatoid arthritis [ Time Frame: 1 hour post injection of 0.1 mg of EC20 ]

Secondary Outcome Measures :
  1. detection of systemic organ inflammation due to rheumatoid arthritis [ Time Frame: 1 hour post injection of 0.1mg of EC20 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00588393

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Eric L Matteson, M.D., M.P.H. Mayo Clinic

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eric L. Matteson, M.D., M.P. H., Mayo Clinic Identifier: NCT00588393     History of Changes
Other Study ID Numbers: 06-002680
First Posted: January 8, 2008    Key Record Dates
Last Update Posted: April 16, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Multiple Sclerosis
Crohn Disease
Lupus Erythematosus, Systemic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases