A Study of FolateScan in Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Study of 99mTc-EC20 Imaging (FolateScan) in Participants With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237405
• Other study ID #: Pro00018123
• Secondary ID: Protocol H7L-MC-
• Status: Completed
• Phase: N/A
• First received: October 26, 2010
• Last updated: November 26, 2012
• Start date: October 2010
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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).

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Kraus	Eli Lilly and Company, Endocyte

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):25 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Intensity and location of uptake of 99mTc-EC20	These data will be collected at a single timepoint (baseline) only and participants will not be further followed.	Baseline	No
Secondary	Correlation of knee symptoms and knee uptake of 99mTc-EC20	This analysis will be performed from data collected at a single timepoint (baseline) only and participants will not be further followed.	Baseline	No
Secondary	Correlation of 99mTc-EC20 uptake and biomarkers	This analysis will be performed from data collected at a single timepoint (baseline) only and participants will not be further followed.	Baseline	No
Secondary	Correlation of knee radiographic OA and knee uptake of 99mTc-EC20	This analysis will be performed from data collected at a single timepoint (baseline) only and participants will not be further followed.	Baseline	No