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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009329
Receipt No. R000010811
Scientific Title Study of Clinical Usefulness of 18F-fluorothymidine(FLT) PET/CT in Ditection of Peritoneal Metastases of Gastric Cancer
Date of disclosure of the study information 2012/11/13
Last modified on 2015/05/13

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Basic information
Public title Study of Clinical Usefulness of 18F-fluorothymidine(FLT) PET/CT in Ditection of Peritoneal Metastases of
Gastric Cancer
Acronym Study of Usefulness of 18F-FLT PET/CT in Peritoneal Metastases of Gastric Cancer
Scientific Title Study of Clinical Usefulness of 18F-fluorothymidine(FLT) PET/CT in Ditection of Peritoneal Metastases of
Gastric Cancer
Scientific Title:Acronym Study of Usefulness of 18F-FLT PET/CT in Peritoneal Metastases of Gastric Cancer
Region
Japan

Condition
Condition Gastric cancer patients with peritoneal
metastases
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm usefulness of 18F-FLT PET/CT in the diagnosis of peritoneal metastases of gastric cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Sensitivity of 18F-FLT PET/CT in the diagnosis of peritoneal metastases of gastric cancer.
Key secondary outcomes Safety of 18F-FLT
Sensitivity of 18F-FLT PET/CT in the diagnosis of primary or metastatic lesion of gastric cancer.

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
Interventions/Control_1 Injection of 2-8 MBq/kg 18F-FLT,
PET/CT imaging study of one hour, and
blood examinations after one week of
inspections.
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 [A-part]
1.Equal to or over 20 years.
2.Established diagnosis of gastric cancer
by histology or cytology.
3.Rough peritoneal metastases are
detected by diagnostic imaing performed
within 4 weeks.
4.Performance status:0-2.
5.Main organs functions must be normal.
6.Written informed concent can be
obtained.

[B-part]
1.Equal to or over 20 years.
2.Established diagnosis of gastric cancer
by histology or cytology.
3.Peritoneal metastases are detected by
diagnostic laparoscopy or surgical
finding performed within 4 weeks.
4.Performance status:0-2.
5.Main organs functions must be normal.
6.Written informed concent can be
Key exclusion criteria 1.Peritoneal metastases detected
only by cytology of ascites.
2.Patients who have alcoholic hyper-
sensitivity.
3.Patients with active infection.
4.Pregnant women or women who have the
possibility to be pregnant or lactating
woman.
5.Patients who are considered to be
ineligible by referring physician.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhide Yamada
Organization National Cancer Center Hospital in Japan
Division name Department of Gastrointestinal Oncology
Zip code
Address Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL 03-3542-2511
Email yayamada@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Honma
Organization National Cancer Center Hospital in Japan
Division name Department of Gastrointestinal Oncology
Zip code
Address Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email yohonma@ncc.go.jp

Sponsor
Institute Department of Gastrointestinal Oncology,
National Cancer Center Hospital in Japan
Institute
Department

Funding Source
Organization Department of Gastrointestinal Oncology,
National Cancer Center Hospital in Japan
Organization
Division
Category of Funding Organization Other
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 YES
Study ID_1 2012-039
Org. issuing International ID_1 IRB of National Cancer Center Hospital in Japan
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立がん研究センター中央病院(東京都)
National Cancer Center Hospital(Tokyo)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 13 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
2012 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 08 Day
Last follow-up date
2015 Year 05 Month 01 Day
Date of closure to data entry
2015 Year 05 Month 01 Day
Date trial data considered complete
2015 Year 05 Month 01 Day
Date analysis concluded
2015 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 11 Month 13 Day
Last modified on
2015 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010811

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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