UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dynamic study of FDG-PET/CT
Title of the study (Brief title)	Dynamic study of FDG-PET/CT
Region	Japan

Condition
Condition	lung cancer, malignant lymphoma, uterine cancer, ovarian cancer, renal cancer
Classification by specialty	Medicine in general Pneumology Chest surgery Obsterics and gynecology Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the early and delayed phases of FDG-PET/CT for the patient that malignant tumor is suspected. To evaluate the diagnostic ability in the detection of malignant lesions by addition of the early and delayed phases.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To be able to predict the histology of lesions by dynamic uptake pattern in the lesions obtained by addition of early and delayed phase.
Key secondary outcomes

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	Other
Interventions/Control_1	Addition of early and delayed phases to usual imaging.
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	4 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients that malignant tumor is suspected
Key exclusion criteria	Patients with much body movement
Target sample size	50

Research contact person
Name of lead principal investigator	Masafumi Harada
Organization	Tokushima University Hospital
Division name	Radiology
Address	2-50-1, Kuramoto-cho, Tokushima
TEL	088-631-3111
Email	otomi.yoichi@tokushima-u.ac.jp

Public contact
Name of contact person	Yoichi Otomi
Organization	Tokushima University Hospital
Division name	Radiology
Address	2-50-1, Kuramoto-cho, Tokushima
TEL	088-631-3111
Homepage URL
Email	otomi.yoichi@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital
Institute
Department

Funding Source
Organization	Tokushima University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 10 Day
Anticipated trial start date	2016 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 08 Day
Last modified on	2017 Year 08 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027601