68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)
August 18, 2022 updated by: Carina Mari Aparici
This is a Phase III study to evaluate 68Ga Citrate PET/MRI for detection of origin of fever of unknown origin.
Study Overview
Status
Withdrawn
Conditions
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 Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Palo Alto, California, United States, 94305
- Stanford University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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:
67Ga-Citrate will be used as the radiotracer for a regular medical care SPECT scan
Other Names:
Imaging with 68Ga-Citrate PET/MRI
Other Names:
Imaging with 68Ga-Citrate PET/MRI
Other Names:
Imaging with 67Ga-Citrate radiotracer.
SPECT scan will be conducted as part of regular medical care.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Uptake detected by investigational imaging agent
Time Frame: Up to 12 months
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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.
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Up to 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carina Mari Aparici, MD, clinical professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 15, 2019
Primary Completion (ANTICIPATED)
December 20, 2020
Study Completion (ANTICIPATED)
December 20, 2021
Study Registration Dates
First Submitted
October 23, 2019
First Submitted That Met QC Criteria
October 23, 2019
First Posted (ACTUAL)
October 25, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 22, 2022
Last Update Submitted That Met QC Criteria
August 18, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-49104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.