68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)
NCT ID: NCT04139395
Last Updated: 2022-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2019-01-15
2021-12-20
Brief Summary
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Detailed Description
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We propose the following aim:
• To evaluate 68Ga Citrate PET/MRI for detection of origin of fever in patients with fever of unknown origin.
Patients 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic 68Ga-Citrate PET/MRI Imaging
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.
68Ga-Citrate PET/MRI
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.
67Ga-Citrate SPECT
67Ga-Citrate will be used as the radiotracer for a regular medical care SPECT scan
Positron Emission Tomography
Imaging with 68Ga-Citrate PET/MRI
Magnetic Resonance Imaging
Imaging with 68Ga-Citrate PET/MRI
SPECT
Imaging with 67Ga-Citrate radiotracer. SPECT scan will be conducted as part of regular medical care.
Interventions
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68Ga-Citrate PET/MRI
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.
67Ga-Citrate SPECT
67Ga-Citrate will be used as the radiotracer for a regular medical care SPECT scan
Positron Emission Tomography
Imaging with 68Ga-Citrate PET/MRI
Magnetic Resonance Imaging
Imaging with 68Ga-Citrate PET/MRI
SPECT
Imaging with 67Ga-Citrate radiotracer. SPECT scan will be conducted as part of regular medical care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient with diagnosis of FUO.
* Patient is capable of complying with study procedures.
* Patient can remain still for duration of imaging procedure.
* Able to provide written consent.
Exclusion Criteria
* Metallic implants (contraindicated for MRI).
* History of renal insufficiency (only for MRI contrast administration).
* Inability to lie still for the entire imaging time.
* Inability to complete the needed investigational and standard of care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.
* Known allergy, hypersensitivity, or intolerance to the investigational product or its excipients.
18 Years
ALL
No
Sponsors
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Carina Mari Aparici
OTHER
Responsible Party
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Carina Mari Aparici
Clinical Professor, Radiology/ Nuclear Medicine
Principal Investigators
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Carina Mari Aparici, MD
Role: PRINCIPAL_INVESTIGATOR
clinical professor
Locations
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Stanford University
Palo Alto, California, United States
Countries
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Other Identifiers
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IRB-49104
Identifier Type: -
Identifier Source: org_study_id
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