A Study of FolateScan in Patients With Knee Osteoarthritis

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Endocyte
Information provided by (Responsible Party):
Virginia Kraus, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01237405
First received: October 26, 2010
Last updated: November 26, 2012
Last verified: November 2012

October 26, 2010
November 26, 2012
October 2010
October 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01237405 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Study of FolateScan in Patients With Knee Osteoarthritis
Study of 99mTc-EC20 Imaging (FolateScan) in Participants 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.

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

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

whole blood, serum, urine, synovial fluid

Non-Probability Sample

Males and females over the age of 18 years with at least one symptomatic knee with evidence of osteoarthritis on radiograph.

Knee Osteoarthritis
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 Name: (FolateScan Imaging Drug)
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).

Intervention: Drug: 99mTc-EC20
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
October 2012
October 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01237405
Pro00018123, Protocol H7L-MC-MDAB(b)
Yes
Virginia Kraus, Duke University Medical Center
Virginia Kraus
  • Eli Lilly and Company
  • Endocyte
Principal Investigator: Virginia B Kraus, MD, PhD Duke University
Duke University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP