UMIN-CTR Clinical Trial

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

Fever of unknown origin (FUO)

Classification by specialty

Medicine in general	Clinical immunology	Infectious disease
Radiology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name

Organization

National Center for Global Health and Medicine

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2014

Year

07

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

07

Month

26

Day

Last modified on

2019

Year

03

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017006