68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)
Study Details
Study Description
Brief Summary
This is a Phase III study to evaluate 68Ga Citrate PET/MRI for detection of origin of fever of unknown origin.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: 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.
Other Names:
Drug: 67Ga-Citrate SPECT
67Ga-Citrate will be used as the radiotracer for a regular medical care SPECT scan
Other Names:
Device: Positron Emission Tomography
Imaging with 68Ga-Citrate PET/MRI
Other Names:
Device: Magnetic Resonance Imaging
Imaging with 68Ga-Citrate PET/MRI
Other Names:
Device: SPECT
Imaging with 67Ga-Citrate radiotracer. SPECT scan will be conducted as part of regular medical care.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Uptake detected by investigational imaging agent [Up to 12 months]
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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University | Palo Alto | California | United States | 94305 |
Sponsors and Collaborators
- Carina Mari Aparici
Investigators
- Principal Investigator: Carina Mari Aparici, MD, clinical professor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-49104