UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of 18F-FDG uptake for detecting lymph node metastasis of gastric cancer
Title of the study (Brief title)	Evaluation of 18F-FDG uptake for detecting lymph node metastasis of gastric cancer
Region	Japan

Condition
Condition	Advanced gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the relationship between 18F-FDG uptake and the presence/absence of metastasis in individual lymph nodes on a one-to-one basis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between 18F-FDG uptake and lymph node involvement
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	(1) adenocarcinoma of the stomach confirmed by pathological examination (2) diagnosis of advanced gastric cancer on preoperative CT scan or endoscopic examination (3) necessity of gastrectomy for curative or palliative intent (4) normal heart, renal,and liver function (5) European clinical oncology group performance status (ECOG PS) 0 or 1
Key exclusion criteria	(1) severe drug allergy (2) diabetes mellitus (3) any severe ongoing comorbidity (4) prior malignant diseases (5) synchronous malignant diseases other than gastric cancer (6) contraindication of FDG PET including pregnancy
Target sample size	30

Research contact person
Name of lead principal investigator	Yasuyuki Seto
Organization	University of Tokyo Hospital
Division name	Department of Gastrointestinal Surgery
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	+81-3-3815-5411
Email	seto-tky@umin.ac.jp

Public contact
Name of contact person	Yasuyuki Seto
Organization	University of Tokyo Hospital
Division name	Department of Gastrointestinal Surgery
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	+81-3-3815-5411
Homepage URL
Email	seto-tky@umin.ac.jp

Sponsor
Institute	University of Tokyo Hospital
Institute
Department

Funding Source
Organization	operating cost of Department of Gastrointestinal surgery
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 05 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 04 Day
Anticipated trial start date	2012 Year 07 Month 01 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	Published
URL releasing results
Results
Other related information	prospective study

Management information
Registered date	2014 Year 05 Month 12 Day
Last modified on	2017 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015620