Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT02893293
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2016-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010020', 'term': 'Osteonecrosis'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mairead@stanford.edu', 'phone': '(650) 725-2548', 'title': 'Heike Daldrup-Link, MD', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 week period (20 minute treatment and 1 week follow-up) plus follow-up visits for approximately 1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Ferumoxytol-enhanced MRI', 'description': 'Patients scheduled for routine decompression surgery and autologous stem cell transplant receive ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration), and follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-ferumoxytol Enhanced MRI', 'description': 'Patients scheduled for routine decompression surgery and autologous stem cell transplant receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Signal to Noise Ratio (SNR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferumoxytol-enhanced MRI', 'description': 'Patients scheduled for routine decompression surgery and autologous stem cell transplant receive ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration), and follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.'}, {'id': 'OG001', 'title': 'Non-ferumoxytol Enhanced MRI', 'description': 'Patients scheduled for routine decompression surgery and autologous stem cell transplant receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.82', 'spread': '12.43', 'groupId': 'OG000'}, {'value': '129.56', 'spread': '10.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value less than the a priori threshold of 0.05 was considered statistically significant.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mixed effects model including a random effect term accounting for correlation among the measures with a same patient.'}], 'paramType': 'MEAN', 'timeFrame': 'week 1 postsurgery', 'description': 'SNR is a measurement that compares the strength of a signal to the level of background noise. It is often expressed in decibels (dB) and is calculated by dividing the signal power by the noise power. A ratio greater than 1:1 indicates that there is more signal than noise.\n\nFirst, for each lesion the MR signal intensity (SI) of the lesion and the SI of the background (= noise in the image) was measured, then the SI of the lesion was divided by the SI of the noise to obtain the signal to noise ratio. Then, the mean SNR and standard deviation was calculated for the different groups of lesions and compared to the mean SNR between treated versus not treated lesions and treated lesions at different time points after the treatment using statistical tests.', 'unitOfMeasure': 'dB', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol'}, {'type': 'PRIMARY', 'title': 'T2*-Relaxation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferumoxytol-enhanced MRI', 'description': 'Patients scheduled for routine decompression surgery and autologous stem cell transplant receive ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration), and follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.'}, {'id': 'OG001', 'title': 'Non-ferumoxytol Enhanced MRI', 'description': 'Patients scheduled for routine decompression surgery and autologous stem cell transplant receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.04', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '2.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value less than the a priori threshold of 0.05 was considered statistically significant.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mixed effects model including a random effect term accounting for correlation among the measures with a same patient.'}], 'paramType': 'MEAN', 'timeFrame': 'week 1 postsurgery', 'description': "T2\\* relaxation time is a measure of how quickly transverse magnetization decays in magnetic resonance imaging (MRI). It's a key factor in image contrast in gradient-echo (GRE) sequences and is used in many MRI applications, such as perfusion imaging, susceptibility-weighted imaging, and functional imaging. Lower T2\\* relaxation times indicate greater contrast agent uptake in cells.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol'}, {'type': 'PRIMARY', 'title': 'Evaluation of Treatment Response to Decompression Surgery and Stem Cell Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Femur', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferumoxytol-enhanced MRI', 'description': 'Patients scheduled for routine decompression surgery and autologous stem cell transplant receive ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration), and follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.'}, {'id': 'OG001', 'title': 'Non-ferumoxytol Enhanced MRI', 'description': 'Patients scheduled for routine decompression surgery and autologous stem cell transplant receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'one year', 'description': 'Number of femurs that did not collapse by 1 year follow up. Evaluation of progression of osteonecrosis via scale 1-4, bone marrow edema, collapse of subchondral fractures.', 'unitOfMeasure': 'Femur', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Femur', 'denomUnitsSelected': 'Femur', 'populationDescription': 'Long-term follow up was conducted in the ferumoxytol group only'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ferumoxytol-enhanced MRI', 'description': 'Patients scheduled for routine decompression surgery and autologous stem cell transplant receive ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration), and follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.'}, {'id': 'FG001', 'title': 'Non-ferumoxytol Enhanced MRI', 'description': 'Patients scheduled for routine decompression surgery and autologous stem cell transplant receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ferumoxytol-enhanced MRI', 'description': 'Patients scheduled for routine decompression surgery and autologous stem cell transplant receive ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration), and follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.'}, {'id': 'BG001', 'title': 'Non-ferumoxytol Enhanced MRI', 'description': 'Patients scheduled for routine decompression surgery and autologous stem cell transplant receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-11', 'size': 1631088, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-30T16:07', 'hasProtocol': True}, {'date': '2023-06-20', 'size': 427930, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-18T18:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2016-07-27', 'resultsFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2016-09-02', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-31', 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Signal to Noise Ratio (SNR)', 'timeFrame': 'week 1 postsurgery', 'description': 'SNR is a measurement that compares the strength of a signal to the level of background noise. It is often expressed in decibels (dB) and is calculated by dividing the signal power by the noise power. A ratio greater than 1:1 indicates that there is more signal than noise.\n\nFirst, for each lesion the MR signal intensity (SI) of the lesion and the SI of the background (= noise in the image) was measured, then the SI of the lesion was divided by the SI of the noise to obtain the signal to noise ratio. Then, the mean SNR and standard deviation was calculated for the different groups of lesions and compared to the mean SNR between treated versus not treated lesions and treated lesions at different time points after the treatment using statistical tests.'}, {'measure': 'T2*-Relaxation Time', 'timeFrame': 'week 1 postsurgery', 'description': "T2\\* relaxation time is a measure of how quickly transverse magnetization decays in magnetic resonance imaging (MRI). It's a key factor in image contrast in gradient-echo (GRE) sequences and is used in many MRI applications, such as perfusion imaging, susceptibility-weighted imaging, and functional imaging. Lower T2\\* relaxation times indicate greater contrast agent uptake in cells."}, {'measure': 'Evaluation of Treatment Response to Decompression Surgery and Stem Cell Transplant', 'timeFrame': 'one year', 'description': 'Number of femurs that did not collapse by 1 year follow up. Evaluation of progression of osteonecrosis via scale 1-4, bone marrow edema, collapse of subchondral fractures.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteonecrosis']}, 'referencesModule': {'references': [{'pmid': '26656202', 'type': 'BACKGROUND', 'citation': 'Muehe AM, Feng D, von Eyben R, Luna-Fineman S, Link MP, Muthig T, Huddleston AE, Neuwelt EA, Daldrup-Link HE. Safety Report of Ferumoxytol for Magnetic Resonance Imaging in Children and Young Adults. Invest Radiol. 2016 Apr;51(4):221-227. doi: 10.1097/RLI.0000000000000230.'}, {'pmid': '27174199', 'type': 'BACKGROUND', 'citation': 'Nejadnik H, Lenkov O, Gassert F, Fretwell D, Lam I, Daldrup-Link HE. Macrophage phagocytosis alters the MRI signal of ferumoxytol-labeled mesenchymal stromal cells in cartilage defects. Sci Rep. 2016 May 13;6:25897. doi: 10.1038/srep25897.'}, {'pmid': '30224340', 'type': 'RESULT', 'citation': 'Theruvath AJ, Nejadnik H, Muehe AM, Gassert F, Lacayo NJ, Goodman SB, Daldrup-Link HE. Tracking Cell Transplants in Femoral Osteonecrosis with Magnetic Resonance Imaging: A Proof-of-Concept Study in Patients. Clin Cancer Res. 2018 Dec 15;24(24):6223-6229. doi: 10.1158/1078-0432.CCR-18-1687. Epub 2018 Sep 17.'}], 'seeAlsoLinks': [{'url': 'http://daldrup-link-lab.stanford.edu/', 'label': 'Pediatric Molecular Imaging Program'}]}, 'descriptionModule': {'briefSummary': 'The goal of the project is to evaluate osteonecrosis before and after decompression surgery with ferumoxytol-enhanced MRI.', 'detailedDescription': 'The goal of the project is to evaluate osteonecrosis before and after decompression surgery with ferumoxytol-enhanced MRI.\n\nThe investigators approach relies on the FDA-approved iron supplement ferumoxytol (Feraheme), which is used off label as a contrast agent for MRI. Ferumoxytol is composed of iron oxide nanoparticles, which provide a strong T1- and T2-signal on magnetic resonance (MR) images and are taken up by cells in bone marrow.\n\n20 patients will undergo MRI before and after decompression surgery and transplantation of bone marrow derived cells. 10 patients will receive a single intravenous injection of ferumoxytol prior to their surgery. 10 additional patients will serve as untreated controls. The investigators hypothesize that MR images after intravenous injection of ferumoxytol will improve lesion detection and allow to track transplanted bone marrow cells. MR imaging findings will be correlated with clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteonecrosis\n* planned decompression surgery with autologous stem cell transplant\n\nExclusion Criteria:\n\n* Contraindications for magnetic resonance imaging\n* Hemosiderosis/hemochromatosis ( patients can still be included in the non-ferumoxytol arm)'}, 'identificationModule': {'nctId': 'NCT02893293', 'acronym': 'Osteonecro', 'briefTitle': 'Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI', 'orgStudyIdInfo': {'id': 'IRB-20253(osteonecrosis)'}, 'secondaryIdInfos': [{'id': 'PEDSBONE0006', 'type': 'OTHER', 'domain': 'OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ferumoxytol-enhanced MRI', 'description': 'Patients receive a ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration) prior to routine decompression surgery and autologous stem cell transplant. Follow-up imaging with magnetic resonance imaging will be conducted in regular intervals for evaluation of the response to treatment.', 'interventionNames': ['Drug: Ferumoxytol-enhanced magnetic resonance imaging', 'Device: Magentic Resonance Imaging']}, {'type': 'SHAM_COMPARATOR', 'label': 'Non-ferumoxytol enhanced MRI', 'description': 'Patients scheduled for routine decompression surgery and autologous stem cell transplant will receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.', 'interventionNames': ['Device: Magentic Resonance Imaging']}], 'interventions': [{'name': 'Ferumoxytol-enhanced magnetic resonance imaging', 'type': 'DRUG', 'description': 'Eligible patients receive a single ferumoxytol-dose and follow-up magnetic resonance imaging to evaluate success of stem cell transplant', 'armGroupLabels': ['Ferumoxytol-enhanced MRI']}, {'name': 'Magentic Resonance Imaging', 'type': 'DEVICE', 'otherNames': ['MRI'], 'description': 'Both arms will receive MRI', 'armGroupLabels': ['Ferumoxytol-enhanced MRI', 'Non-ferumoxytol enhanced MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital", 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Heike Daldrup-Link, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology', 'investigatorFullName': 'Heike E Daldrup-Link', 'investigatorAffiliation': 'Stanford University'}}}}