68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)

NCT ID: NCT04139395

Last Updated: 2022-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2021-12-20

Brief Summary

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This is a Phase III study to evaluate 68Ga Citrate PET/MRI for detection of origin of fever of unknown origin.

Detailed Description

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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

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Fever of Unknown Origin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

68Ga-Citrate PET/MRI

Intervention Type DRUG

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 SPECT

Intervention Type DRUG

67Ga-Citrate will be used as the radiotracer for a regular medical care SPECT scan

Positron Emission Tomography

Intervention Type DEVICE

Imaging with 68Ga-Citrate PET/MRI

Magnetic Resonance Imaging

Intervention Type DEVICE

Imaging with 68Ga-Citrate PET/MRI

SPECT

Intervention Type DEVICE

Imaging with 67Ga-Citrate radiotracer. SPECT scan will be conducted as part of regular medical care.

Interventions

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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.

Intervention Type DRUG

67Ga-Citrate SPECT

67Ga-Citrate will be used as the radiotracer for a regular medical care SPECT scan

Intervention Type DRUG

Positron Emission Tomography

Imaging with 68Ga-Citrate PET/MRI

Intervention Type DEVICE

Magnetic Resonance Imaging

Imaging with 68Ga-Citrate PET/MRI

Intervention Type DEVICE

SPECT

Imaging with 67Ga-Citrate radiotracer. SPECT scan will be conducted as part of regular medical care.

Intervention Type DEVICE

Other Intervention Names

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Gallium-68- Citrate Gallium-67- Citrate PET MRI Medical Imaging, Magnetic Resonance/ Nuclear Magnetic Resonance Single Photon Emission Computed Tomography/Computed Tomography

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carina Mari Aparici

OTHER

Sponsor Role lead

Responsible Party

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Carina Mari Aparici

Clinical Professor, Radiology/ Nuclear Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Carina Mari Aparici, MD

Role: PRINCIPAL_INVESTIGATOR

clinical professor

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-49104

Identifier Type: -

Identifier Source: org_study_id

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