68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)

Study Overview
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Brief Summary
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This is a Phase III study to evaluate 68Ga Citrate PET/MRI for detection of origin of fever of unknown origin.

Detailed Description
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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). 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.

Official Title
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68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)

Conditions
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Fever of Unknown Origin

Intervention / Treatment
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* Drug: 68Ga-Citrate PET/MRI
* Drug: 67Ga-Citrate SPECT
* Device: Positron Emission Tomography
* Device: Magnetic Resonance Imaging
* Device: SPECT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is >/=18 years old at the time of the scan. 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: Patient is pregnant or nursing. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic 68Ga-Citrate PET/MRI Imaging<br>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. | Drug: 68Ga-Citrate PET/MRI<br>* 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.<br>* Other names: Gallium-68- Citrate;Drug: 67Ga-Citrate SPECT<br>* 67Ga-Citrate will be used as the radiotracer for a regular medical care SPECT scan<br>* Other names: Gallium-67- Citrate;Device: Positron Emission Tomography<br>* Imaging with 68Ga-Citrate PET/MRI<br>* Other names: PET;Device: Magnetic Resonance Imaging<br>* Imaging with 68Ga-Citrate PET/MRI<br>* Other names: Medical Imaging, Magnetic Resonance/ Nuclear Magnetic Resonance;Device: SPECT<br>* Imaging with 67Ga-Citrate radiotracer. SPECT scan will be conducted as part of regular medical care.<br>* Other names: Single Photon Emission Computed Tomography/Computed Tomography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake detected by investigational imaging agent | 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. | Up to 12 months |