UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009329 |
|---|---|
| Receipt number | 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 09:18:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yohonma@ncc.go.jp
Sponsor or person
Institute
Department of Gastrointestinal Oncology,
National Cancer Center Hospital in Japan
Institute
Department
Personal name
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
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
Value
https://center6.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 |
