FolateScan in Autoimmune Disease

NCT ID: NCT00588393

Last Updated: 2010-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2007-12-31

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.

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.

Conditions

Rheumatoid Arthritis; Osteoarthritis; Multiple Sclerosis; Crohn's Disease; Systemic Lupus Erythematosus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

FolateScan (Technetium Tc 99mEC20)

0.1 mg. of EC20 labeled with 20-25 mCi of technetium-99m followed by FolateScan

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Endocyte

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Eric L Matteson, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 18952896 (View on PubMed)

Other Identifiers

06-002680

Identifier Type: -

Identifier Source: org_study_id