UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Functional imaging for advanced cancer treatment
Title of the study (Brief title)	FACT
Region	Japan

Condition
Condition	Advanced cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Breast surgery Obsterics and gynecology Urology Radiology Oral surgery Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the most appropriate diagnostic method to detect resistant tumor tissues in advanced cancer using PET probes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Analyzing the correlation between PET tracer accumulation and effects of the treatment, such as radiotherapy and chemotherapy.
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	Maneuver
Interventions/Control_1	Functional PET 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Advanced cancer
Key exclusion criteria	Patients who do not take any treatments.
Target sample size	100

Research contact person
Name of lead principal investigator	Hidehiko Okazawa
Organization	University of Fukui
Division name	Biomedical Imaging Research Center
Address	23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Fukui, 910-1193 Japan
TEL	0776-61-8491
Email	okazawa@u-fukui.ac.jp

Public contact
Name of contact person	Hidehiko Okazawa
Organization	University of Fukui
Division name	Biomedical Imaging Research Center
Address	23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Fukui, 910-1193 Japan
TEL	0776-61-8491
Homepage URL
Email	bircfukui@gmail.com

Sponsor
Institute	Biomedical Imaging Research Center, University of Fukui
Institute
Department

Funding Source
Organization	JST
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	2011 Year 02 Month 23 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 11 Month 30 Day
Anticipated trial start date	2010 Year 12 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0155635
Results
Other related information

Management information
Registered date	2011 Year 02 Month 23 Day
Last modified on	2016 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005621