- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00588393
FolateScan in Autoimmune Disease
Study of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory Diseases
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
detection of joint inflammation due to active rheumatoid arthritis
Time Frame: 1 hour post injection of 0.1 mg of EC20
|
1 hour post injection of 0.1 mg of EC20
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
detection of systemic organ inflammation due to rheumatoid arthritis
Time Frame: 1 hour post injection of 0.1mg of EC20
|
1 hour post injection of 0.1mg of EC20
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Gastrointestinal Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Gastroenteritis
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Multiple Sclerosis
- Arthritis
- Arthritis, Rheumatoid
- Lupus Erythematosus, Systemic
- Crohn Disease
Other Study ID Numbers
- 06-002680
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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