68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Uptake detected by investigational imaging agent
Study Overview
Brief Summary
This is a Phase III study to evaluate 68Ga Citrate PET/MRI for detection of origin of fever of unknown origin.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: 68Ga-Citrate PET/MRI (Drug)
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.
Intervention: 67Ga-Citrate SPECT (Drug)
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.
Intervention: Positron Emission Tomography (Device)
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.
Intervention: Magnetic Resonance Imaging (Device)
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.
Intervention: SPECT (Device)
Outcomes
Primary Outcomes
Uptake detected by investigational imaging agent
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Carina Mari Aparici
Clinical Professor, Radiology/ Nuclear Medicine
Stanford University