Clinical trial NCT01237405: A Study of FolateScan in Patients With Knee Osteoarthritis
Official title: Study of 99mTc-EC20 Imaging (FolateScan) in Participants With Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: osteoarthritis
nuclear medicine
macrophages
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Endocyte
First posted: 2010-11-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females over the age of 18 years with at least one symptomatic knee with evidence of osteoarthritis on radiograph.

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 knee osteoarthritis (OA). Twenty five participants with symptomatic unilateral or bilateral knee OA will undergo a one-time evaluation of the knee as follows: knee radiography, FolateScan of the knees and whole body, musculoskeletal exam, questionnaires, sampling of blood, urine and synovial fluid for analysis of inflammatory markers. Data analysis will be cross-sectional and include a comparison of the location and intensity of EC20 uptake with the following: radiographic knee OA severity, clinical measures of disease severity, cytokine expression, and synovial fluid cell count.

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 Criteria: 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 Criteria: 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.

Primary outcomes:
measure: Frequency of knee uptake of 99mTc-EC20
timeFrame: Baseline
Secondary outcomes:
measure: Intensity and location of uptake of 99mTc-EC20
timeFrame: Baseline
measure: Correlation of knee symptoms and knee uptake of 99mTc-EC20
timeFrame: Baseline
measure: Correlation of 99mTc-EC20 uptake and biomarkers
timeFrame: Baseline
measure: Correlation of knee radiographic OA and knee uptake of 99mTc-EC20
timeFrame: Baseline
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Virginia B Kraus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matteson EL, Lowe VJ, Prendergast FG, Crowson CS, Moder KG, Morgenstern DE, Messmann RA, Low PS. Assessment of disease activity in rheumatoid arthritis using a novel folate targeted radiopharmaceutical Folatescan. Clin Exp Rheumatol. 2009 Mar-Apr;27(2):253-9.
citation: Haraden CA, Huebner JL, Hsueh MF, Li YJ, Kraus VB. Synovial fluid biomarkers associated with osteoarthritis severity reflect macrophage and neutrophil related inflammation. Arthritis Res Ther. 2019 Jun 13;21(1):146. doi: 10.1186/s13075-019-1923-x.
citation: Kraus VB, McDaniel G, Huebner JL, Stabler TV, Pieper CF, Shipes SW, Petry NA, Low PS, Shen J, McNearney TA, Mitchell P. Direct in vivo evidence of activated macrophages in human osteoarthritis. Osteoarthritis Cartilage. 2016 Sep;24(9):1613-21. doi: 10.1016/j.joca.2016.04.010. Epub 2016 Apr 12.