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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic 68Ga-Citrate PET/MRI Imaging | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-Citrate PET/MRI | Drug | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carina Mari Aparici, MD | clinical professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D005335 | Fever of Unknown Origin |
| ID | Term |
|---|---|
| D005334 | Fever |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C103850 | gallium citrate |
| D049268 | Positron-Emission Tomography |
| D008279 | Magnetic Resonance Imaging |
| D015899 | Tomography, Emission-Computed, Single-Photon |
| D000072098 | Single Photon Emission Computed Tomography Computed Tomography |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| 67Ga-Citrate SPECT | Drug | 67Ga-Citrate will be used as the radiotracer for a regular medical care SPECT scan |
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| Positron Emission Tomography | Device | Imaging with 68Ga-Citrate PET/MRI |
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| Magnetic Resonance Imaging | Device | Imaging with 68Ga-Citrate PET/MRI |
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| SPECT | Device | Imaging with 67Ga-Citrate radiotracer. SPECT scan will be conducted as part of regular medical care. |
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| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |