A Study of FolateScan in Patients With Knee Osteoarthritis

This study is currently recruiting participants.
Verified by Duke University, November 2010
First Received: October 26, 2010 Last Updated: November 8, 2010

Sponsor:
Duke University
Collaborators:
Eli Lilly and Company Endocyte
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT01237405

Purpose
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.

Condition
Knee Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Study of 99mTc-EC20 Imaging (FolateScan) in Participants With Knee Osteoarthritis

Further study details as provided by Duke University: Primary Outcome Measures:

  • Frequency of knee uptake of 99mTc-EC20 [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    These data will be collected at a single timepoint (baseline) only and participants will not be further followed.

Secondary Outcome Measures:

  • Intensity and location of uptake of 99mTc-EC20 [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    These data will be collected at a single timepoint (baseline) only and participants will not be further followed.

  • Correlation of knee symptoms and knee uptake of 99mTc-EC20 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This analysis will be performed from data collected at a single timepoint (baseline) only and participants will not be further followed.

  • Correlation of 99mTc-EC20 uptake and biomarkers [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This analysis will be performed from data collected at a single timepoint (baseline) only and participants will not be further followed.

  • Correlation of knee radiographic OA and knee uptake of 99mTc-EC20 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This analysis will be performed from data collected at a single timepoint (baseline) only and participants will not be further followed.

Biospecimen Retention: Samples With DNA
whole blood, serum, urine, synovial fluid

Estimated Enrollment: 25
Study Start Date: October 2010

Groups/Cohorts
Knee Osteoarthritis
Unilateral or bilateral knee osteoarthritis on radiograph associated with knee pain on most days of any one-month in the last year in at least one knee. Age > 18 years old

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
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
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.

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.

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