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
  Purpose

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 Intervention
Knee Osteoarthritis
Drug: 99mTc-EC20

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Study of 99mTc-EC20 Imaging (FolateScan) in Participants With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

whole blood, serum, urine, synovial fluid


Enrollment: 25
Study Start Date: October 2010
Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: (FolateScan Imaging Drug)

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237405

Locations
United States, North Carolina
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
  More Information

Publications:
Responsible Party: Virginia Kraus, Professor, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01237405     History of Changes
Other Study ID Numbers: Pro00018123, Protocol H7L-MC-MDAB(b)
Study First Received: October 26, 2010
Last Updated: November 26, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Duke University:
osteoarthritis
nuclear medicine
macrophages

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014