Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT01541358
Status:
TERMINATED
Last Update Posted:
2017-06-14
First Post:
2012-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001859', 'term': 'Bone Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'AQuon@mednet.ucla.edu', 'phone': '310-983-1419', 'title': 'Andrew Quon, MD', 'organization': 'David Geffen School of Medicine at UCLA'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Low participant enrollment. The uptake of fluoride ions is better in bone remodeling processes, while purely bone lytic processes have a lower uptake, or no uptake at all, which is a limitation of F-18 NaF PET/CT bone scan.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)', 'description': 'Patients undergo fluorine F 18 sodium fluoride PET/CT scan.\n\nfluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT scan\n\npositron emission tomography/computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT scan', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)', 'description': 'Patients were injected with approximately 5mCi F18 NaF and underwent a PET/CT scan approximately 60 minutes later.\n\nA whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'an estimated average of 2 hours', 'description': 'F-18 NaF is a positron emission tomography (PET) bone imaging agent that targets changes in the bone. The fluoride ions are taken up in areas of the bone that have increased bone remodeling (bone repair) and increased blood flow, which is indicative of diseases such as cancer.', 'unitOfMeasure': 'lesions detected by F18 NaF', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all study participants.'}, {'type': 'SECONDARY', 'title': 'Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)', 'description': 'Patients were injected with approximately 5mCi F18 NaF and undergo a PET/CT scan approximately 60 minutes later.\n\nA whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'an estimated average of 2 hours', 'description': 'Specificity is the ability of a test to correctly determine the absence of disease (true negative). This study determined how accurately F18 NaF PET/CT performed at detecting the absence of disease.\n\nThe calculation for specificity is TN / (TN + FP), where:\n\nTN = the participant was a true negative (the lesion was not detected on F18 NaF PET/CT and the patient does not have the disease) FP = the participant was a false positive (the lesion was falsely detected on the F18 NaF PET/CT and the patient does not have the disease) The result is expressed as a percentage.', 'unitOfMeasure': 'percentage of specificity', 'reportingStatus': 'POSTED', 'populationDescription': 'Both participants were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)', 'description': 'Patients were injected with approximately 5mCi F18 NaF and underwent a PET/CT scan approximately 60 minutes later.\n\nA whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'an estimated average of 2 hours', 'description': 'Sensitivity is the ability of a test to correctly identify those with the disease (true positive rate). This study determined how many lesions were detected by F18 NaF PET/CT compared to the known results. The calculation for sensitivity is TP / (TP+FN), where:\n\nTP = true positive (the lesion was accurately detected on both F18 NaF and comparison study) FN = false negative (the lesion was not detected on the PET/CT but was detected on the comparison study)\n\nThe result is expressed as the percentage of confirmed lesions across all participants that were also detected by F18 NaF PET/CT.', 'unitOfMeasure': 'percentage of sensitivity', 'reportingStatus': 'POSTED', 'populationDescription': 'Both participants were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)', 'description': 'Patients were injected with approximately 5mCi F18 NaF and undergo a PET/CT scan approximately 60 minutes later.\n\nA whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Low accrual and no funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-12', 'studyFirstSubmitDate': '2012-02-23', 'resultsFirstSubmitDate': '2017-02-14', 'studyFirstSubmitQcDate': '2012-02-23', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-12', 'studyFirstPostDateStruct': {'date': '2012-02-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy', 'timeFrame': 'an estimated average of 2 hours', 'description': 'F-18 NaF is a positron emission tomography (PET) bone imaging agent that targets changes in the bone. The fluoride ions are taken up in areas of the bone that have increased bone remodeling (bone repair) and increased blood flow, which is indicative of diseases such as cancer.'}], 'secondaryOutcomes': [{'measure': 'Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy', 'timeFrame': 'an estimated average of 2 hours', 'description': 'Specificity is the ability of a test to correctly determine the absence of disease (true negative). This study determined how accurately F18 NaF PET/CT performed at detecting the absence of disease.\n\nThe calculation for specificity is TN / (TN + FP), where:\n\nTN = the participant was a true negative (the lesion was not detected on F18 NaF PET/CT and the patient does not have the disease) FP = the participant was a false positive (the lesion was falsely detected on the F18 NaF PET/CT and the patient does not have the disease) The result is expressed as a percentage.'}, {'measure': 'Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy', 'timeFrame': 'an estimated average of 2 hours', 'description': 'Sensitivity is the ability of a test to correctly identify those with the disease (true positive rate). This study determined how many lesions were detected by F18 NaF PET/CT compared to the known results. The calculation for sensitivity is TP / (TP+FN), where:\n\nTP = true positive (the lesion was accurately detected on both F18 NaF and comparison study) FN = false negative (the lesion was not detected on the PET/CT but was detected on the comparison study)\n\nThe result is expressed as the percentage of confirmed lesions across all participants that were also detected by F18 NaF PET/CT.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bone Cancer']}, 'descriptionModule': {'briefSummary': 'This clinical trial studies fluorine F-18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) in diagnosing bone tumors in patients with cancer. Diagnostic procedures, such as fluorine F-18 sodium fluoride PET/CT, may help find and diagnose bone cancer', 'detailedDescription': 'The objective of the study is to use 18F sodium fluoride (fluorine F-18 sodium fluoride) PET/CT scanning to detect and characterize lesions in patients who have suspected skeletal malignancy. We hypothesize that scanning with 18F-NaF (fluorine F-18 sodium fluoride) is more sensitive for skeletal abnormalities and may better characterize lesions than conventional imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred for evaluation of suspected skeletal cancer\n* Patients must understand and voluntarily sign an informed consent form after the contents have been fully explained to them\n\nExclusion Criteria:\n\n* Patients who cannot complete a PET/CT scan\n* Pregnant women\n* Healthy volunteers'}, 'identificationModule': {'nctId': 'NCT01541358', 'briefTitle': 'Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer', 'orgStudyIdInfo': {'id': 'IRB-23082'}, 'secondaryIdInfos': [{'id': 'NCI-2012-00138', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'SU-02162012-9128', 'type': 'OTHER', 'domain': 'Stanford University'}, {'id': 'VAR0074', 'type': 'OTHER', 'domain': 'OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (fluorine F 18 sodium fluoride PET/CT)', 'description': 'Patients undergo fluorine F 18 sodium fluoride PET/CT scan.', 'interventionNames': ['Radiation: fluorine F 18 sodium fluoride', 'Procedure: positron emission tomography/computed tomography']}], 'interventions': [{'name': 'fluorine F 18 sodium fluoride', 'type': 'RADIATION', 'otherNames': ['18 F-NaF', 'F-18 NaF'], 'description': 'Undergo fluorine F 18 sodium fluoride PET/CT scan', 'armGroupLabels': ['Diagnostic (fluorine F 18 sodium fluoride PET/CT)']}, {'name': 'positron emission tomography/computed tomography', 'type': 'PROCEDURE', 'description': 'Undergo fluorine F 18 sodium fluoride PET/CT scan', 'armGroupLabels': ['Diagnostic (fluorine F 18 sodium fluoride PET/CT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Andrew Quon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Radiology', 'investigatorFullName': 'Andrew Quon', 'investigatorAffiliation': 'Stanford University'}}}}