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A Study of FolateScan in Patients With Knee Osteoarthritis

NCT01237405 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2012-11-27

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Virginia B Kraus, MD, PhD · Duke University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01237405 on ClinicalTrials.gov