Fever of unknown origin (FUO)
Conditions
Interventions
FDG-PET/CT examination and Gallium SPECT examination.
Sponsors
National Center for Global Health and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Patients who were 20 years old or older when they signed the informed consent form. 2. Patients with a fever of 38degree Cercius or higher (axillary temperature) on two occasions per week or more during the 14 days prior to the provision of consent to participate to this study. 3. Patients in whom a cerebrospinal fluid (CSF) examination performed within 3 weeks after fever onset produced normal results or patients who did not exhibit neck stiffness or a disturbance of consciousness. 4. Patients whose fever origin remained undiagnosed even after the completion of blood tests, a thoracic-abdominal CT examination, and other tests listed below within 3 weeks before the provision of consent to participate in this study. Patients, including those with sepsis, whose focus of infection was unknown were regarded as having FUO. -complete blood cell count, blood sedimentation, blood chemistry (T-Bil, AST, ALT, LDH, ALP, gammaGTP, BUN, Cr, Na, K, Cl, Ca, BS), serological tests (CRP, TP, Alb, ferritin, RF, antinuclear antibody), thyroid tests (F-T3, F-T4, TSH), viral antibody (HIV-Ab, CMV-IgM, EB VCA IgM), urine test, blood culture, and echocardiography. 5. Patients who provided written informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Patients who had undergone surgery within 1 month. 2. Pregnant or lactating patients. 3. Patients with uncontrolled diabetes mellitus. 4. Patients with neutrophil counts lower than 500/micro Litter 5. Patients who had already undergone an FDG-PET/CT or gallium SPECT examination within 3 weeks. 6. Patients who were suspected of not being able to provide full voluntary agreement to participate in this research study because of mental and/or legal problems.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study will be the difference in the sensitivity of FDG-PET/CT and that of gallium SPECT for the detection of fever origin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints <Based on the Central Image Interpretation Committee's report> - Positive lesions on FDG-PET/CT images - Sensitivity, specificity, positive predictive value, accuracy, and contribution ratio of FDG-PET/CT - Positive lesions on gallium SPECT images - Sensitivity, specificity, positive predictive value, accuracy, and contribution ratio of gallium SPECT <Based on the case report file completed by the physician in charge> - Clinical impact of FDG-PET/CT on the final diagnosis of FUO. - Clinical impact of gallium SPECT on the final diagnosis of FUO <Additional evaluation> - Consistency of positive lesions identified by the hospital radiologist and that identified by the Central Image Interpretation Committee. | — |
Countries
Japan
Contacts
Public ContactRyogo Minamimoto
National Center for Global Health and Medicine Division of Nuclear Medicine, Department of Radiology.
Outcome results
None listed