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

NCT04139395 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: IRB-49104
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fever of Unknown Origin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Drug: 68Ga-Citrate PET/MRI; Drug: 67Ga-Citrate SPECT; Device: Positron Emission Tomography; Device: Magnetic Resonance Imaging; Device: SPECT

Interventions

68Ga-Citrate PET/MRI 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.

Also known as: Gallium-68- Citrate

Diagnostic 68Ga-Citrate PET/MRI Imaging

67Ga-Citrate SPECT DRUG

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

Also known as: Gallium-67- Citrate

Diagnostic 68Ga-Citrate PET/MRI Imaging

Positron Emission Tomography DEVICE

Imaging with 68Ga-Citrate PET/MRI

Also known as: PET

Diagnostic 68Ga-Citrate PET/MRI Imaging

Magnetic Resonance Imaging DEVICE

Imaging with 68Ga-Citrate PET/MRI

Also known as: MRI, Medical Imaging, Magnetic Resonance/ Nuclear Magnetic Resonance

Diagnostic 68Ga-Citrate PET/MRI Imaging

SPECT DEVICE

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

Also known as: Single Photon Emission Computed Tomography/Computed Tomography

Diagnostic 68Ga-Citrate PET/MRI Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carina Mari Aparici: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Fever of Unknown Origin

Interventions

gallium citrate; Positron-Emission Tomography; Magnetic Resonance Imaging; Tomography, Emission-Computed, Single-Photon; Single Photon Emission Computed Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Fever; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Radiography; Tomography, X-Ray

Study Officials

• Carina Mari Aparici, MD

  clinical professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor, Radiology/ Nuclear Medicine

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: January 15, 2019
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2021
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)