Back to results68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)
Primary Purpose
Fever of Unknown Origin
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
68Ga-Citrate PET/MRI
67Ga-Citrate SPECT
Positron Emission Tomography
Magnetic Resonance Imaging
SPECT
Sponsored by
About this trial
This is an interventional diagnostic trial for Fever of Unknown Origin
Eligibility 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.
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic 68Ga-Citrate PET/MRI Imaging
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04139395
Brief Title
68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)
Official Title
68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Not feasible at this time.
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
December 20, 2020 (Anticipated)
Study Completion Date
December 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carina Mari Aparici
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever of Unknown Origin
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic 68Ga-Citrate PET/MRI Imaging
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
68Ga-Citrate PET/MRI
Other Intervention Name(s)
Gallium-68- Citrate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
67Ga-Citrate SPECT
Other Intervention Name(s)
Gallium-67- Citrate
Intervention Description
67Ga-Citrate will be used as the radiotracer for a regular medical care SPECT scan
Intervention Type
Device
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
PET
Intervention Description
Imaging with 68Ga-Citrate PET/MRI
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
MRI, Medical Imaging, Magnetic Resonance/ Nuclear Magnetic Resonance
Intervention Description
Imaging with 68Ga-Citrate PET/MRI
Intervention Type
Device
Intervention Name(s)
SPECT
Other Intervention Name(s)
Single Photon Emission Computed Tomography/Computed Tomography
Intervention Description
Imaging with 67Ga-Citrate radiotracer. SPECT scan will be conducted as part of regular medical care.
Primary Outcome Measure Information:
Title
Uptake detected by investigational imaging agent
Description
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.
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carina Mari Aparici, MD
Organizational Affiliation
clinical professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)
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