A Study of FolateScan in Patients With Knee Osteoarthritis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. 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). |
Drug: 99mTc-EC20
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:
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Outcome Measures
Primary Outcome Measures
- Frequency of knee uptake of 99mTc-EC20 [Baseline]
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 [Baseline]
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 [Baseline]
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 [Baseline]
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 [Baseline]
This analysis will be performed from data collected at a single timepoint (baseline) only and participants will not be further followed.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Virginia Kraus
- Eli Lilly and Company
- Endocyte
Investigators
- Principal Investigator: Virginia B Kraus, MD, PhD, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00018123
- Protocol H7L-MC-MDAB(b)