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NCT Number: NCT01237405

A Study of FolateScan in Patients With Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

99mTc-EC20

Drug

Study participants underwent a one-time evaluation by FolateScan which entailed a single intravenous injection of 99mTc-EC20 (total volume of 1.0 to 2.0 ml administered over a period of 30 seconds with radioactive dose between 20 and 25 mCi). A total of three imaging scans were acquired: an early phase (at ~1 minute) SPECT/CT of both knees; a late phase (at ~60 minutes) SPECT/CT image of both knees; and a late phase (at ~80 minutes) planar image of the whole body was performed (anterior-posterior, and postero-anterior).

Other names: (FolateScan Imaging Drug)

Primary outcomes

  1. Frequency of knee uptake of 99mTc-EC20

    Time frame: Baseline

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

Secondary outcomes

  1. Intensity and location of uptake of 99mTc-EC20

    Time frame: Baseline

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

  2. Correlation of knee symptoms and knee uptake of 99mTc-EC20

    Time frame: Baseline

    This analysis will be performed from data collected at a single timepoint (baseline) only and participants will not be further followed.

  3. Correlation of 99mTc-EC20 uptake and biomarkers

    Time frame: Baseline

    This analysis will be performed from data collected at a single timepoint (baseline) only and participants will not be further followed.

  4. Correlation of knee radiographic OA and knee uptake of 99mTc-EC20

    Time frame: Baseline

    This analysis will be performed from data collected at a single timepoint (baseline) only and participants will not be further followed.

Sponsors and collaborators

Lead sponsor

Virginia Kraus

Other

Collaborators

  • Eli Lilly and Company
  • Endocyte

Registry information

Official study title

Study of 99mTc-EC20 Imaging (FolateScan) in Participants With Knee Osteoarthritis

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Nov 9, 2010
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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