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

Fever of Unknown Origin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04139395
• Other study ID #: IRB-49104
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 15, 2019
• Est. completion date: December 20, 2021

Study information

• Verified date: August 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fever
• Fever of Unknown Origin

Intervention

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

Device:
• Positron Emission Tomography
Imaging with 68Ga-Citrate PET/MRI
• Magnetic Resonance Imaging
Imaging with 68Ga-Citrate PET/MRI
• SPECT
Imaging with 67Ga-Citrate radiotracer. SPECT scan will be conducted as part of regular medical care.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Carina Mari Aparici

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 months