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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014657
Receipt No. R000017006
Scientific Title Application of FDG-PET/CT for fever of unknown origin: a comparative study to Gallium SPECT
Date of disclosure of the study information 2014/07/29
Last modified on 2019/03/18

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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