Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-27 @ 10:02 AM
Study NCT ID:
NCT04139395
Status:
WITHDRAWN
Last Update Posted:
2022-08-22
First Post:
2019-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005335', 'term': 'Fever of Unknown Origin'}], 'ancestors': [{'id': 'D005334', 'term': 'Fever'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C103850', 'term': 'gallium citrate'}, {'id': 'D049268', 'term': 'Positron-Emission Tomography'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D015899', 'term': 'Tomography, Emission-Computed, Single-Photon'}, {'id': 'D000072098', 'term': 'Single Photon Emission Computed Tomography Computed Tomography'}], 'ancestors': [{'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D064847', 'term': 'Multimodal Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Not feasible at this time.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-18', 'studyFirstSubmitDate': '2019-10-23', 'studyFirstSubmitQcDate': '2019-10-23', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uptake detected by investigational imaging agent', 'timeFrame': 'Up to 12 months', 'description': 'The uptake detected on 68Ga Citrate PET/MRI and conventional 67Ga Citrate SPECT will be compared. Outcome will be reported as infectious uptake detected per patient for each imaging method.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fever of Unknown Origin']}, 'descriptionModule': {'briefSummary': 'This is a Phase III study to evaluate 68Ga Citrate PET/MRI for detection of origin of fever of unknown origin.', 'detailedDescription': 'The purpose of this research study is to evaluate a PET tracer (68Ga-Citrate) that can localize the origin of patients diagnosed with fever of unknown origin (FUO) using a PET/MRI scanner. We hope to learn if this can detect FUO better than with the present nuclear imaging standard of care (67Ga SPECT).\n\nWe propose the following aim:\n\n• To evaluate 68Ga Citrate PET/MRI for detection of origin of fever in patients with fever of unknown origin.\n\nPatients disgnosed with fever of unknown origin are injected intravenously (IV) with 370 MBq of 68Ga Citrate. 45-60 minutes later, a whole body PET/MRI images are obtained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is \\>/=18 years old at the time of the scan.\n* Patient with diagnosis of FUO.\n* Patient is capable of complying with study procedures.\n* Patient can remain still for duration of imaging procedure.\n* Able to provide written consent.\n\nExclusion Criteria:\n\n* Patient is pregnant or nursing.\n* Metallic implants (contraindicated for MRI).\n* History of renal insufficiency (only for MRI contrast administration).\n* Inability to lie still for the entire imaging time.\n* Inability to complete the needed investigational and standard of care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).\n* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.\n* Known allergy, hypersensitivity, or intolerance to the investigational product or its excipients.'}, 'identificationModule': {'nctId': 'NCT04139395', 'briefTitle': '68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': '68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)', 'orgStudyIdInfo': {'id': 'IRB-49104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic 68Ga-Citrate PET/MRI Imaging', 'description': 'Participants will receive separate scans, first a SPECT scan following administration of the 67Ga Citrate tracer (standard of care), then a PET/MRI scan following administration of the 68Ga-Citrate tracer (investigational); some participants will also receive IV gadolinium-based contrast injection. Scans will be performed 45-60 minutes following injection of the tracer.', 'interventionNames': ['Drug: 68Ga-Citrate PET/MRI', 'Drug: 67Ga-Citrate SPECT', 'Device: Positron Emission Tomography', 'Device: Magnetic Resonance Imaging', 'Device: SPECT']}], 'interventions': [{'name': '68Ga-Citrate PET/MRI', 'type': 'DRUG', 'otherNames': ['Gallium-68- Citrate'], 'description': 'Participants will be injected intravenously (IV) with 370 MBq of 68Ga Citrate. 45 -60 minutes after the radiopharmaceutical IV administration, whole body data acquisition at the PET/MRI suite will begin.', 'armGroupLabels': ['Diagnostic 68Ga-Citrate PET/MRI Imaging']}, {'name': '67Ga-Citrate SPECT', 'type': 'DRUG', 'otherNames': ['Gallium-67- Citrate'], 'description': '67Ga-Citrate will be used as the radiotracer for a regular medical care SPECT scan', 'armGroupLabels': ['Diagnostic 68Ga-Citrate PET/MRI Imaging']}, {'name': 'Positron Emission Tomography', 'type': 'DEVICE', 'otherNames': ['PET'], 'description': 'Imaging with 68Ga-Citrate PET/MRI', 'armGroupLabels': ['Diagnostic 68Ga-Citrate PET/MRI Imaging']}, {'name': 'Magnetic Resonance Imaging', 'type': 'DEVICE', 'otherNames': ['MRI', 'Medical Imaging, Magnetic Resonance/ Nuclear Magnetic Resonance'], 'description': 'Imaging with 68Ga-Citrate PET/MRI', 'armGroupLabels': ['Diagnostic 68Ga-Citrate PET/MRI Imaging']}, {'name': 'SPECT', 'type': 'DEVICE', 'otherNames': ['Single Photon Emission Computed Tomography/Computed Tomography'], 'description': 'Imaging with 67Ga-Citrate radiotracer. SPECT scan will be conducted as part of regular medical care.', 'armGroupLabels': ['Diagnostic 68Ga-Citrate PET/MRI Imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Carina Mari Aparici, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'clinical professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carina Mari Aparici', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor, Radiology/ Nuclear Medicine', 'investigatorFullName': 'Carina Mari Aparici', 'investigatorAffiliation': 'Stanford University'}}}}