Fever of Unknown OriginPhase 3NCT04139395
68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)
A Phase 3 study testing 68Ga-Citrate PET/MRI, 67Ga-Citrate SPECT and Positron Emission Tomography in people with Fever of Unknown Origin, run by Carina Mari Aparici at 1 site in United States.
Trial summary
This is a Phase III study to evaluate 68Ga Citrate PET/MRI for detection of origin of fever of unknown origin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fever of Unknown Origin
- What is being tested?
- 68Ga-Citrate PET/MRI, 67Ga-Citrate SPECT and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 20 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This is a Phase III study to evaluate 68Ga Citrate PET/MRI for detection of origin of fever of unknown origin.
Read the 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.
- Conditions
- Fever of Unknown Origin
- Being tested
- 68Ga-Citrate PET/MRI, 67Ga-Citrate SPECT, Positron Emission Tomography, Magnetic Resonance Imaging, SPECT
- Medical subject headings
- Fever of Unknown Origin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-Citrate PET/MRIDrug
Also called Gallium-68- Citrate
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.
67Ga-Citrate SPECTDrug
Also called Gallium-67- Citrate
67Ga-Citrate will be used as the radiotracer for a regular medical care SPECT scan
Positron Emission TomographyDevice
Also called PET
Imaging with 68Ga-Citrate PET/MRI
Magnetic Resonance ImagingDevice
Also called MRI, Medical Imaging, Magnetic Resonance/ Nuclear Magnetic Resonance
Imaging with 68Ga-Citrate PET/MRI
SPECTDevice
Also called Single Photon Emission Computed Tomography/Computed Tomography
Imaging with 67Ga-Citrate radiotracer. SPECT scan will be conducted as part of regular medical care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 68Ga-Citrate PET/MRI; Drug: 67Ga-Citrate SPECT; Device: Positron Emission Tomography; Device: Magnetic Resonance Imaging; Device: SPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start15 Jan 2019
- Primary completion20 Dec 2020 (estimated)
- Study completion20 Dec 2021 (estimated)
Why it stopped: Not feasible at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fever of Unknown OriginStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carina Mari Aparici
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carina Mari Aparici, Stanford University
- Investigators
- Carina Mari Aparici, MD, Principal investigator, clinical professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139395
- Sponsor's protocol ID
- IRB-49104
- Status last verified
- Aug 2022
- First submitted
- 23 Oct 2019
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)
- ClinicalTrials.gov ID
- NCT04139395
- Acronym / sponsor ID
- IRB-49104
- Conditions
- Fever of Unknown Origin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not feasible at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Carina Mari ApariciUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic 68Ga-Citrate PET/MRI Imaging | Experimental | Drug: 68Ga-Citrate PET/MRI, Drug: 67Ga-Citrate SPECT, Device: Positron Emission Tomography, Device: Magnetic Resonance Imaging, Device: SPECTParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-Citrate PET/MRIAlso: Gallium-68- CitrateParticipants 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. | Drug | Diagnostic 68Ga-Citrate PET/MRI Imaging |
| 67Ga-Citrate SPECTAlso: Gallium-67- Citrate67Ga-Citrate will be used as the radiotracer for a regular medical care SPECT scan | Drug | Diagnostic 68Ga-Citrate PET/MRI Imaging |
| Positron Emission TomographyAlso: PETImaging with 68Ga-Citrate PET/MRI | Device | Diagnostic 68Ga-Citrate PET/MRI Imaging |
| Magnetic Resonance ImagingAlso: MRI, Medical Imaging, Magnetic Resonance/ Nuclear Magnetic ResonanceImaging with 68Ga-Citrate PET/MRI | Device | Diagnostic 68Ga-Citrate PET/MRI Imaging |
| SPECTAlso: Single Photon Emission Computed Tomography/Computed TomographyImaging with 67Ga-Citrate radiotracer. SPECT scan will be conducted as part of regular medical care. | Device | Diagnostic 68Ga-Citrate PET/MRI Imaging |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carina Mari Aparici, MD principal investigator
clinical professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 68Ga-Citrate PET/MRI, 67Ga-Citrate SPECT and Positron Emission Tomography in people with Fever of Unknown Origin, run by Carina Mari Aparici at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake detected by investigational imaging agent (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.