Status:
COMPLETED
A Study of FolateScan in Patients With Knee Osteoarthritis
Lead Sponsor:
Virginia Kraus
Collaborating Sponsors:
Eli Lilly and Company
Endocyte
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate 99mTc - EC20 imaging (FolateScan), a Nuclear Medicine imaging technology that enables localization of activated macrophages in the joints of participants with ...
Detailed Description
Each study day will on average last one day per individual and each individual will be followed for development of an Adverse Event for 7 days
Eligibility Criteria
Inclusion
- Unilateral or bilateral knee OA; Kellgren Lawrence grade 1-4; Knee pain on most days of any one-month in the last year in at least one knee; Age \> 18 years old.
Exclusion
- Arthroscopic knee surgery within the previous 12 months; Intra-articular injection or systemic (oral, IV, IM) steroid within previous 6 months; Any knee replacement; Current enrollment in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug used in this study); Pregnancy; Positive serum beta HCG within 48 hours prior to 99mTc-EC20 administration and/or lactation; Rheumatoid arthritis or other inflammatory arthropathy; Avascular necrosis; Periarticular fracture; Current anticoagulant therapy; Current immune modulator therapy, or any such therapy within 4 weeks of study procedures; Inability to discontinue use of NSAIDS within 3 days of study procedures (low dose aspirin of up to 325 mg per day is permitted); Must be able to stop Folic Acid containing vitamins 24 hrs before study; Paget's disease; Villonodular synovitis; Joint infection; Ochronosis; Neuropathic arthropathy; Acromegaly; Hemochromatosis; Wilson's disease; Osteochondromatosis; Personnel directly affiliated with this study or their immediate family members; Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01237405
Start Date
October 1 2010
End Date
October 1 2012
Last Update
November 27 2012
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710