NCT01237405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

1 year

First QC Date

October 26, 2010

Last Update Submit

November 26, 2012

Conditions

Knee Osteoarthritis

Keywords

osteoarthritisnuclear medicinemacrophages

Outcome Measures

Primary Outcomes (1)

  • Frequency of knee uptake of 99mTc-EC20

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

    Baseline

Secondary Outcomes (4)

  • Intensity and location of uptake of 99mTc-EC20

    Baseline

  • Correlation of knee symptoms and knee uptake of 99mTc-EC20

    Baseline

  • Correlation of 99mTc-EC20 uptake and biomarkers

    Baseline

  • Correlation of knee radiographic OA and knee uptake of 99mTc-EC20

    Baseline

Study Arms (1)

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

Interventions

99mTc-EC20DRUG

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).

Also known as: (FolateScan Imaging Drug)
Knee Osteoarthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

  • 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.

    PMID: 19473565RESULT

  • 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.

    PMID: 31196179DERIVED

  • 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.

    PMID: 27084348DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, urine, synovial fluid

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Virginia B Kraus, MD, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 26, 2010

First Posted

November 9, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2012

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

US(1)