UMIN-CTR Clinical Trial

Basic information
Public title	Application of FDG-PET/CT for fever of unknown origin: a comparative study to Gallium SPECT
Acronym	JPET-FUO
Scientific Title	Application of FDG-PET/CT for fever of unknown origin: a comparative study to Gallium SPECT
Scientific Title:Acronym	JPET-FUO
Region	Japan

Condition
Condition	Fever of unknown origin (FUO)
Classification by specialty	Medicine in general Clinical immunology Infectious disease Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To demonstrate the usefulness of FDG-PET/CT for the diagnosis of fever of unknown origin (FUO), we will compare the sensitivity of FDG-PET/CT and that of gallium SPECT for the detection of fever origin.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	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.
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine Device,equipment
Interventions/Control_1	FDG-PET/CT examination and Gallium SPECT examination.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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.
Target sample size	180

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Ryogo Minamimoto
Organization	National Center for Global Health and Medicine
Division name	Division of Nuclear Medicine, Department of Radiology.
Zip code
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, JAPAN
TEL	03-5273-6881
Email	fumeinetsu@clock.ocn.ne.jp

Public contact
1st name of contact person	1st name Middle name Last name Ryogo Minamimoto
Organization	National Center for Global Health and Medicine
Division name	Division of Nuclear Medicine, Department of Radiology.
Zip code
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, JAPAN
TEL	03-5273-6881
Homepage URL
Email	fumeinetsu@clock.ocn.ne.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立国際医療研究センター病院（東京都）、東北大学病院（宮城県）、公立大学法人横浜市立大学附属病院（神奈川県）、東京医科歯科大学医学部付属病院（東京都）、山形大学医学部付属病院（山形県）、大阪市立大学医学部付属病院（大阪府）、香川大学医学部付属病院（香川県）、大阪大学医学部付属病院（大阪府)、慶応義塾大学病院（東京都）、宮崎大学医学部付属病院（宮崎県）、公立松任石川中央病院（石川県）、社会福祉法人恩師財団大阪府済生会中津病院（大阪府）、東京都健康長寿医療センター（東京都）、独協医科大学病院（栃木県）、京都大学医学部附属病院（京都府）、長崎大学病院（長崎県）、九州大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 22 Day
Date of IRB	2014 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 07 Month 26 Day
Last modified on	2019 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017006