Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT01237405
Status:
COMPLETED
Last Update Posted:
2012-11-27
First Post:
2010-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of FolateScan in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, serum, urine, synovial fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-26', 'studyFirstSubmitDate': '2010-10-26', 'studyFirstSubmitQcDate': '2010-11-08', 'lastUpdatePostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of knee uptake of 99mTc-EC20', 'timeFrame': 'Baseline', 'description': 'These data will be collected at a single timepoint (baseline) only and participants will not be further followed.'}], 'secondaryOutcomes': [{'measure': 'Intensity and location of uptake of 99mTc-EC20', 'timeFrame': 'Baseline', 'description': 'These data will be collected at a single timepoint (baseline) only and participants will not be further followed.'}, {'measure': 'Correlation of knee symptoms and knee uptake of 99mTc-EC20', 'timeFrame': 'Baseline', 'description': 'This analysis will be performed from data collected at a single timepoint (baseline) only and participants will not be further followed.'}, {'measure': 'Correlation of 99mTc-EC20 uptake and biomarkers', 'timeFrame': 'Baseline', 'description': 'This analysis will be performed from data collected at a single timepoint (baseline) only and participants will not be further followed.'}, {'measure': 'Correlation of knee radiographic OA and knee uptake of 99mTc-EC20', 'timeFrame': 'Baseline', 'description': 'This analysis will be performed from data collected at a single timepoint (baseline) only and participants will not be further followed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['osteoarthritis', 'nuclear medicine', 'macrophages'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '19473565', 'type': 'RESULT', 'citation': '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': '31196179', 'type': 'DERIVED', 'citation': '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': '27084348', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Males and females over the age of 18 years with at least one symptomatic knee with evidence of osteoarthritis on radiograph.', 'healthyVolunteers': False, 'eligibilityCriteria': "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.\n\nExclusion 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."}, 'identificationModule': {'nctId': 'NCT01237405', 'briefTitle': 'A Study of FolateScan in Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Study of 99mTc-EC20 Imaging (FolateScan) in Participants With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'Pro00018123'}, 'secondaryIdInfos': [{'id': 'Protocol H7L-MC-MDAB(b)', 'type': 'OTHER_GRANT', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Knee Osteoarthritis', 'description': '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.\n\nStudy 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).', 'interventionNames': ['Drug: 99mTc-EC20']}], 'interventions': [{'name': '99mTc-EC20', 'type': 'DRUG', 'otherNames': ['(FolateScan Imaging Drug)'], 'description': '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).', 'armGroupLabels': ['Knee Osteoarthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Virginia B Kraus, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Kraus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, {'name': 'Endocyte', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Virginia Kraus', 'investigatorAffiliation': 'Duke University'}}}}