NCT04139395

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Carina Mari Aparici · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fever of Unknown Origin

Interventions

Type	Name	Description
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.
DRUG	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
DEVICE	Magnetic Resonance Imaging	Imaging with 68Ga-Citrate PET/MRI
DEVICE	SPECT	Imaging with 67Ga-Citrate radiotracer. SPECT scan will be conducted as part of regular medical care.

Timeline

• Start date: 2019-01-15
• Primary completion: 2020-12-20
• Completion: 2021-12-20
• First posted: 2019-10-25
• Last updated: 2022-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study